The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for Ccg Cerclage System.
| Device ID | K932024 |
| 510k Number | K932024 |
| Device Name: | CCG CERCLAGE SYSTEM |
| Classification | Cerclage, Fixation |
| Applicant | ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Contact | Webb |
| Correspondent | Webb ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-26 |
| Decision Date | 1995-02-14 |