The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Novation Crown Cup With Integrip Acetabular Shell, Cluster-hole.
| Device ID | K102975 |
| 510k Number | K102975 |
| Device Name: | NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Vladislava Zaitseva |
| Correspondent | Vladislava Zaitseva EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | LPH |
| Subsequent Product Code | JDI |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-06 |
| Decision Date | 2010-11-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862038852 | K102975 | 000 |
| 10885862038760 | K102975 | 000 |
| 10885862038777 | K102975 | 000 |
| 10885862038784 | K102975 | 000 |
| 10885862038791 | K102975 | 000 |
| 10885862038807 | K102975 | 000 |
| 10885862038814 | K102975 | 000 |
| 10885862038821 | K102975 | 000 |
| 10885862038838 | K102975 | 000 |
| 10885862038845 | K102975 | 000 |
| 10885862038753 | K102975 | 000 |