The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Exactech Novation Empire Acetabular Augment With Integrip Model 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13.
| Device ID | K101761 |
| 510k Number | K101761 |
| Device Name: | EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13 |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Darrell Kassner |
| Correspondent | Darrell Kassner 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 |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-23 |
| Decision Date | 2010-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862038913 | K101761 | 000 |
| 10885862238368 | K101761 | 000 |
| 10885862238351 | K101761 | 000 |
| 10885862238344 | K101761 | 000 |
| 10885862238337 | K101761 | 000 |
| 10885862039132 | K101761 | 000 |
| 10885862039125 | K101761 | 000 |
| 10885862039118 | K101761 | 000 |
| 10885862039101 | K101761 | 000 |
| 10885862039095 | K101761 | 000 |
| 10885862039088 | K101761 | 000 |
| 10885862038968 | K101761 | 000 |
| 10885862038951 | K101761 | 000 |
| 10885862238375 | K101761 | 000 |
| 10885862238382 | K101761 | 000 |
| 10885862038906 | K101761 | 000 |
| 10885862038890 | K101761 | 000 |
| 10885862038883 | K101761 | 000 |
| 10885862038876 | K101761 | 000 |
| 10885862038869 | K101761 | 000 |
| 10885862038746 | K101761 | 000 |
| 10885862038739 | K101761 | 000 |
| 10885862038722 | K101761 | 000 |
| 10885862230287 | K101761 | 000 |
| 10885862159687 | K101761 | 000 |
| 10885862038937 | K101761 | 000 |
| 10885862038920 | K101761 | 000 |
| 10885862038944 | K101761 | 000 |