FDA 510(k) Applications for Medical Device:
Methyl Methacrylate For Cranioplasty
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K011399 | BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, | WARSAW | IN | 46581-0587 |
| K990290 | BIOMET, INC. |
AIRPORT INDUSTRIAL PARK, | WARSAW | IN | 46581-0587 |
| K043280 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K012569 | BIOMET, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581-0587 |
| K040152 | Cardinal Health |
1500 WAUKEGAN RD. | MCGAW PARK | IL | 60085 |
| K071791 | Codman & Shurtleff, Inc. |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K182742 | Dimensional Bioceramics, LLC |
250 Natural Bridges Drive | Santa Cruz | CA | 95050 |
| K011736 | DOCTOR'S RESEARCH GROUP, INC. |
143 WOLCOTT RD. | WOLCOTT | CT | 06716 |
| K091382 | DOCTORS RESEARCH GROUP, INC. |
1331 H STREET NW 12TH FLOOR | WASHINGTON | DC | 20005 |
| K983009 | ETEX CORP. |
350 MASSACHUSETTES AVE., 4FLR | CAMBRIDGE | MA | 02139 |
| K032307 | ETEX CORP. |
UNIVERSITY PARK AT MIT | CAMBRIDGE | MA | 02139 |
| K023575 | IMMEDICA, INC. |
719 A STREET, NE | WASHINGTON | DC | 20002 |
| K070012 | KYUNGWON MEDICAL CO., LTD. |
13340E FIRESTONE BLVD. | SANTA FE SPRINGS | CA | 90670 |
| K973789 | NORIAN CORP. |
10260 BUBB RD. | CUPERTINO | CA | 95014-4166 |
| K232771 | Orthocon, Inc. |
700 Fairfield Avenue - Suite 1 | Stamford | CT | 06902 |
| K221933 | Orthocon, Inc. |
1 Bridge Street - Suite 121 | Irvington | NY | 10533 |
| K231475 | Orthocon, Inc. |
700 Fairfield Avenue - Suite 1 | Stamford | CT | 06902 |
| K241027 | Orthocon, Inc. |
700 Fairfield Ave. - Suite 1 | Stamford | CT | 06902 |
| K953339 | OSTEOGENICS, INC. |
250 EAST ARAPAHO RD. | RICHARDSON | TX | 75081 |
| K964537 | OSTEOGENICS, INC. |
250 EAST ARAPAHO RD. | RICHARDSON | TX | 75081 |
| K051093 | OSTEOPORE, INC. |
958 KRISTIN RIDGE WAY | MILPITAS | CA | 95035 |
| K072601 | OSTEOSYMBIONICS, LLC |
1768 EAST 25TH STREET | CLEVELAND | OH | 44114 |
| K994022 | PARALLAX MEDICAL, INC. |
453 RAVENDALE DR., SUITE B | MOUNTAIN VIEW | CA | 94043 |
| K982040 | POREX SURGICAL, INC. |
4715 ROOSEVELT HWY. | COLLEGE PARK | GA | 30349-2417 |
| K042072 | SKELETAL KINETICS, LLC |
10201 BUBB RD. | CUPERTINO | CA | 95014-4167 |
| K051784 | SKELETAL KINETICS, LLC |
10201 BUBB RD. | CUPERTINO | CA | 95014-4167 |
| K162864 | Skeletal Kinetics, LLC. |
10201 Bubb Road | Cupertino | CA | 95014 |
| K143661 | STRYKER |
750 TRADE CENTRE WAY - SUITE 200 | PORTAGE | MI | 49002 |
| K060763 | Stryker |
750 TRADE CENTRE WAY | PORTAGE | MI | 49002 |
| K043334 | STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE. | KALAMAZOO | MI | 49001 |
| K021440 | STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE. | KALAMAZOO | MI | 49087 |
| K032366 | STRYKER INSTRUMENTS |
4100 EAST MILHAM AVE. | KALAMAZOO | MI | 49087 |
| K991398 | STRYKER LEIBINGER |
4100 EAST MILHAM AVE. | KALAMAZOO | MI | 49001 |
| K012589 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K060445 | SYNTHES (USA) |
1302 WRIGHTS LANE EAST | WEST CHESTER | PA | 19380 |
| K060443 | SYNTHES (USA) |
1302 WRIGHTS LANE EAST | WEST CHESTER | PA | 19380 |
| K041350 | SYNTHES (USA) |
1690 RUSSELL RD. | PAOLI | PA | 19301 |
| K102018 | SYNTHES USA PRODUCTS LLC |
1230 WILSON DRIVE | WEST CHESTER | PA | 19380 |
| K042414 | TECRES |
ONE DEMOCRACY PLAZA | BETHESDA | MD | 20817 |
| K023718 | WALTER LORENZ SURGICAL, INC. |
56 EAST BELL DR. | WARSAW | IN | 46581 |
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