The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Acumatch A-series Connexion Gxl Enhanced Crosslinked Polythylene.
| Device ID | K051556 |
| 510k Number | K051556 |
| Device Name: | ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Diana Taylor |
| Correspondent | Diana Taylor EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-13 |
| Decision Date | 2005-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862010506 | K051556 | 000 |