J-FX CERCLAGE SYSTEM
FDA 510(k) clearance K971682 · decided 1997-06-27
Clearance details
- K-number
- K971682
- Device name
- J-FX CERCLAGE SYSTEM
- Applicant
- Johnson & Johnson Professionals, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-05-06
- Decision date
- 1997-06-27
- Days to decision
- 52 days
- Clearance type
- Traditional
- Product code
- LRN
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| TROCHANTER CABLE GRIP SYSTEM (ADD'L INDICATIONS) (K900926) | Howmedica Corp. | 1990-04-23 |
| SONGER WIRING SYSTEM (K892651) | Danek Medical, Inc. | 1989-07-25 |
| TYPE 316L COTTER WIRE (K864375) | Winn Hirsch & Assoc. | 1987-05-20 |
Recalls involving this device
No recalls on record reference this clearance.