The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Novation Crown Cup Liners; Neutral, Lipped, +5mm Lateralized, +5/10 Degree.
| Device ID | K121392 |
| 510k Number | K121392 |
| Device Name: | NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Lindy Knisely |
| Correspondent | Lindy Knisely EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Product Code | LZO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LPH |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-09 |
| Decision Date | 2013-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862206961 | K121392 | 000 |
| 10885862155528 | K121392 | 000 |
| 10885862155535 | K121392 | 000 |
| 10885862155542 | K121392 | 000 |
| 10885862155580 | K121392 | 000 |
| 10885862206923 | K121392 | 000 |
| 10885862206930 | K121392 | 000 |
| 10885862206947 | K121392 | 000 |
| 10885862206954 | K121392 | 000 |
| 10885862155504 | K121392 | 000 |