K971682 is an FDA 510(k) clearance for the J-FX CERCLAGE SYSTEM. This device is classified as a Wire, Surgical (Class II - Special Controls, product code LRN).
Submitted by Johnson & Johnson Professionals, Inc. (Raynham, US). The FDA issued a Cleared decision on June 27, 1997, 52 days after receiving the submission on May 6, 1997.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3030.
| 510(k) Number | K971682 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 06, 1997 |
| Decision Date | June 27, 1997 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | LRN — Wire, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3030 |