F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE
FDA 510(k) clearance K072432 · decided 2008-01-09
Clearance details
- K-number
- K072432
- Device name
- F3 FRACTURED FINGER FIXATOR, STERILE (MODEL: FCS 400) AND NON STERILE
- Applicant
- Hand Biomechanics Lab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2007-08-29
- Decision date
- 2008-01-09
- Days to decision
- 133 days
- Clearance type
- Traditional
- Product code
- JEC
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Sacramento, CA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| DIGIFIX EXTERNAL FIXATION SYSTEM (K132731) | Virak Orthopedic Research, LLC | 2014-01-10 |
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| LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X (K082679) | Sintea Biotech, Inc. | 2009-04-07 |
| SYNTHES (USA) 2ND GENERATION PELVIC C-CLAMP (K071476) | Synthes (Usa) | 2007-08-24 |
| KLSA MARTIN HAND DISTRACTOR (K042066) | KLS-Martin L.P. | 2004-08-25 |
| FEP FIXATION SYSTEM AND STYLO WRIST FIXATION SYSTEM (K032427) | Meridan Medical | 2003-10-09 |
Recalls involving this device
No recalls on record reference this clearance.