FDA 510(k) Applications for Medical Device:
Component, Traction, Invasive
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K965029 | ACUMED, INC. |
10950 S.W. 5TH ST. | BEAVERTON | OR | 97005 |
| K193256 | Anjon Holdings LLC |
4801 Dawin Road | Jacksonville | FL | 32207 |
| K171863 | Anjon Holdings, LLC |
4801 Dawin Rd | Jacksonville | FL | 32207 |
| K203605 | Arbutus Medical Inc. |
828 10th Ave W, Suite 560 | Vancouver | V5Z 1L8 | |
| K981423 | AUTOGENESIS, INC. |
410 WEST LOMBARD ST., #217 | BALTIMORE | MD | 21201 |
| K013818 | AUTOGENESIS, INC. |
8700 OLD HARFORD RD. | BALTIMORE | MD | 21234 |
| K954838 | BIODYNAMIC TECHNOLOGIES, INC. |
1425 EAST NEWPORT CENTER DR. | DEERFIELD BEACH | FL | 33442 |
| K993099 | DEPUY ACROMED |
325 PARAMOUNT DR. | RAYNHAM | MA | 02767-0350 |
| K984442 | HAND BIOMECHANICS LAB, INC. |
77 SCRIPPS DR., SUITE 104 | SACRAMENTO | CA | 95825 |
| K072432 | HAND BIOMECHANICS LAB, INC. |
77 SCRIPPS DR., SUITE 104 | SACRAMENTO | CA | 95825 |
| K181192 | Hand Biomechanics Lab, Inc. |
77 Scripps Drive, Suite 104 | Sacramento | CA | 95825 |
| K030519 | HAND BIOMECHANICS LAB, INC. |
77 SCRIPPS DR., SUITE 104 | SACRAMENTO | CA | 95825 |
| K971755 | HOWMEDICA CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070 |
| K963614 | HOWMEDICA CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070 |
| K961618 | HOWMEDICA CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070 |
| K954667 | HOWMEDICA CORP. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070 |
| K031941 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K003848 | HOWMEDICA OSTEONICS CORP. |
59 ROUTE 17 SOUTH | ALLENDALE | NJ | 07401-1677 |
| K961916 | HOWMEDICA, INC. |
359 VETERANS BLVD. | RUTHERFORD | NJ | 07070-2584 |
| K042066 | KLS-MARTIN L.P. |
1239-1 ST. JOHN'S IND. PKWY. | JACKSONVILLE | FL | 32246 |
| K032427 | MERIDAN MEDICAL |
3722 AVE. SAUSALITO | IRVINE | CA | 92606 |
| K991732 | OWANDAR MEDICAL LTD |
PO BOX 389 | HP14 3XP | ||
| K082679 | SINTEA BIOTECH, INC. |
407 LINCOLN RD. SUITE 10L | MIAMI BEACH | FL | 33139 |
| K022065 | SINTEA BIOTECH, INC. |
407 LINCOLN RD. SUITE 10L | MIAMI BEACH | FL | 33139 |
| K012193 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K022676 | SMITH & NEPHEW, INC. |
1450 BROOKS RD. | MEMPHIS | TN | 38116 |
| K102885 | STRYKER CORP. |
325 Corporate Drive | Mahwah | NJ | 07430 |
| K163028 | SURGICAL INSTRUMENT SERVICE AND SAVINGS INC |
2747 SW 6TH ST. | REDMOND | OR | 97756 |
| K071476 | SYNTHES (USA) |
1301 GOSHEN PKWY | WEST CHESTER | PA | 19380 |
| K960782 | SYNTHES (USA) |
P.O. BOX 1766 | PAOLI | PA | 19301-1222 |
| K132731 | VIRAK ORTHOPEDIC RESEARCH, LLC |
3416 ROXEE RUN COVE | BARTLETT | TN | 38133 |
| K192465 | Virak Orthopedics, LLC |
620 Essex St | Harrison | NJ | 07029 |
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