FDA 510(k) Applications for Medical Device:
Bone Cement
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K123225 | AAP BIOMATERIALS GMBH & CO. KG |
LAGERSTRASSE 11-15 | DIEBURG | 64807 | |
| K123081 | AAP BIOMATERIALS GMBH & CO. KG |
LAGERSTRASSE 11-15 | DIEBURG | 64807 | |
| K212729 | Biomecanica Industria e Comerciode Produtos Ortopedicos LTDA |
Rua Luiz Pengo 145 | Jau | 17212-811 | |
| K172408 | Biomet Inc |
56 East Bell Drive | Warsaw | IN | 46581 |
| K171540 | Biomet Inc. |
56 East Bell Drive | Warsaw | IN | 46582 |
| K091608 | BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE | WARSAW | IN | 46581-0587 |
| K070015 | BIOMET MANUFACTURING CORP. |
56 EAST BELL DRIVE | WARSAW | IN | 46581-0587 |
| K051496 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46582 |
| K051532 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K092150 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K993836 | BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, | WARSAW | IN | 46581-0587 |
| K030086 | BIOMET, INC. |
56 BELL DR. | WARSAW | IN | 46581-0587 |
| K143100 | Cossington Ltd |
167-169 London Road | Kingston Upon Thames | KT26PT | |
| K143134 | Cossington Ltd |
167-169 London Road | Kingston Upon Thames | KT26PT | |
| K021499 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K023103 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K053003 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K041656 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K053445 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K033563 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K033382 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K023012 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K081155 | DEPUY ORTHOPAEDICS, INC. |
700 ORTHOPAEDIC DRIVE | WARSAW | IN | 46581-0988 |
| K033596 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K021715 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K031430 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K043403 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K000943 | EXACTECH, INC. |
2320 N.W. 66TH CT. | GAINESVILLE | FL | 32653 |
| K193061 | G21 S.r.l |
Via S. Pertini, 8 | San Possidonio | 41039 | |
| K181282 | G21 S.r.l |
Via Sandro Petrini, 8 | San Possidonio | 41039 | |
| K193059 | G21 S.r.l. |
Via S. Pertini, 8 | San Possidonio | 41039 | |
| K173494 | G21 s.r.l. |
Via Sandro Petrini, 8 | San Possidonio | 841039 | |
| K150408 | G21 S.R.L. |
VIA SANDRO PERTINI, 8 | SAN POSSIDONIO | 41039 | |
| K050085 | HERAEUS KULZER GMBH |
GRUNER WEG 11 | HANAU | 63450 | |
| K050854 | HERAEUS KULZER GMBH |
PHILLIP REIS-STRASSE 8/13 | WEHRHEIM | D-61273 | |
| K050855 | HERAEUS KULZER GMBH |
PHILLIP REIS-STRASSE 8/13 | WEHRHEIM | D-61273 | |
| K030903 | HERAEUS KULZER GMBH & CO. KG |
GRUNER WEG 11 | HANAU | D-63450 | |
| K022251 | HERAEUS KULZER GMBH & CO. KG |
GRUNER WEG 11 | HANAU | D-63450 | |
| K030902 | HERAEUS KULZER GMBH & CO. KG |
GRUNER WEG 11 | HANAU | D-63450 | |
| K031673 | HERAEUS KULZER GMBH & CO. KG |
GRUNER WEG 11 | HANAU | D-63450 | |
| K153737 | HERAEUS MEDICAL GMBH |
PHILIPP-REIS-STR. 8-13 | WEHRHEIM | 61273 | |
| K190766 | Heraeus Medical GmbH |
Philipp-Reis-Strasse 8/13 | Wehrheim | 61273 | |
| K182260 | Heraeus Medical GmbH |
Philipp-Reis-Str. 8-13 | Wehrheim | 61273 | |
| K213812 | Heraeus Medical GmbH |
Philipp-Reis-Str. 8/13 | Wehrheim | 61273 | |
| K150119 | HERAEUS MEDICAL GMBH |
PHILIPP-REIS-STR. 8-13 | WEHRHEIM | 61273 | |
| K210607 | Heraeus Medical GmbH |
Phillipp-Reis-Str. 8/13 | Wehrheim | 61273 | |
| K202475 | Heraeus Medical GmbH |
Philipp-Reis-Str. 8/13 | Wehrheim | 61273 | |
| K142157 | HERAEUS MEDICAL GMBH |
PHILIPP-REIS-STR. 8-13 | WEHRHEIM | 61273 | |
| K030904 | Heraeus Medical Gmbh Technology |
Philipp-Reis Strabe 8/13 | Wehrheim | 61273 | |
| K053198 | HOWMEDICA OSTEONICS CORP |
325 CORPORATE DR. | MAHWAH | NJ | 07430 |
| K014199 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K013755 | IMMEDICA, INC. |
615 7TH ST. NE | WASHINGTON | DC | 20002 |
| K010586 | MERCK BIOMATERIAL GMBH |
FRANKFURTER STR. 250, | DARMSTADT | D-64271 | |
| K211869 | Ormed Grup Medikal Turizm Saglik Hizmetleri Sanayi Ve |
Ticaret Limited S | Ankara | 06200 | |
| K210125 | OSARTIS GmbH |
Auf der Beune 101 | Munster | 64839 | |
| K210120 | Osartis GmbH |
Auf der Beune 101 | Munster | 64839 | |
| K202458 | Osartis GmbH |
Auf der Beune 101 | Munster | 64839 | |
| K192394 | OSARTIS GmbH |
Lagerstrasse 11-15 | Dieburg | 64807 | |
| K192379 | OSARTIS GmbH |
Lagerstrasse 11-15 | Dieburg | 64807 | |
| K033509 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K022688 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K001160 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K032945 | STRYKER CORP. |
4100 E. MILHAM AVE. | KALAMAZOO | MI | 49001 |
| K002652 | STRYKER CORP. |
4100 E MILHAM AVE. | PORTAGE | MI | 49002-9704 |
| K062553 | STRYKER ORTHOPAEDICS |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K170802 | Synthes (USA) Products, LLC |
1301 Goshen Parkway | West Chester | PA | 19380 |
| K211163 | Tecres S.p.A. |
Via Andrea Doria 6 | Sommacampagna | 37066 | |
| K092773 | TECRES SPA |
7 Trail House Court | Rockville | MD | 20850 |
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