510(k) K031941
- Device
- HOFFMANN II COMPACT BALTIMORE COUPLING
- Applicant
- HOWMEDICA OSTEONICS CORP.
- 510(k) number
- K031941
- Product code
- JEC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-07-24
- Date received
- 2003-06-24
- Regulation
- 888.3040
- Classification name
- Component, Traction, Invasive
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- VIVIAN KELLY
- Address
- 59 Rte. 17 S. Allendale NJ US 07401 07401
FDA Registration Numbers#
- 1220246
- 1720929
- 3036756245
- 2031910
- 3038503932
- 3004464325
- 3015207155
- 3006694268
- 3005893246
- 2029275
- 1526439
- 1818910
- 1066368
- 3006946279
- 2183449
- 2919128
- 1828464
- 1057946
- 3005061536
- 2090040
- 3008812560
- 1834379
- 1423662
- 3009350690
- 3003860203
- 3025141
- 1054811
- 9680825
- 3008534770
- 3000270450
- 3010667733
- 3008744062
- 3009417901
- 3010860227
- 3010287687
- 1020279
- 3013004243
- 1825034
- 3033509898
- 9610905
- 3013176080
- 3006015326
- 3008114965
- 3011500362
- 2032112
- 1047843
- 8031020
- 2011171
- 2531232
- 1043534
- 3013055499
- 1828288
- 3015882686
- 3035366890
- 1043653
- 3032391
- 3007366790
- 3023852420
- 3008868758
- 2028632
- 1526534
- 2032098
- 3034676720
- 3025603301
Source Documents#
Other 510(k) Records For Product Code JEC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K203605 | SteriTrak | Arbutus Medical, Inc. | 2021-04-23 |
| K193256 | Anjon Bremer Halo System | Anjon Holdings, LLC | 2020-03-02 |
| K192465 | DigiFix Sterile Kit | Virak Orthopedics, LLC | 2019-10-10 |
| K181192 | PIP Fix | Hand Biomechanics Lab, Inc. | 2018-10-22 |
| K171863 | Anjon Bremer Halo System | Anjon Holdings, LLC | 2018-03-19 |
| K163028 | Medline ReNewal Reprocessed Stryker External Fixation Devices | Surgical Instrument Service and Savings, Inc. | 2016-12-28 |
| K132731 | DIGIFIX EXTERNAL FIXATION SYSTEM | Virak Orthopedic Research, LLC | 2014-01-10 |
| K102885 | HOFFMANN II EXTERNAL FIXATION SYSTEM LINE EXTENSION MODEL 4920-1-010, 4920-1-020, 4920-1-030, 4920-1-100, HOFFMANN II EX | Stryker Corp. | 2011-01-14 |
| K082679 | LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X | Sintea Biotech, Inc. | 2009-04-07 |
| K072432 | F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE | Hand Biomechanics Lab, Inc. | 2008-01-09 |
| K071476 | SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP | Synthes (Usa) | 2007-08-24 |
| K042066 | KLSA MARTIN HAND DISTRACTOR | KLS-Martin L.P. | 2004-08-25 |
| K032427 | FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM | Meridan Medical | 2003-10-09 |
| K030519 | WRISTJACK SYSTEM (REMANUFACTURED), STERILE AND NON-STERILE, MODELS CFD-147-RS, CFD-247-RNS | Hand Biomechanics Lab, Inc. | 2003-06-10 |
| K022676 | ORTHOGUARD AB ANTIMICROBIAL SLEEVE | Smith & Nephew, Inc. | 2002-09-23 |
Legacy Summary#
summary
FDA Review#
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