The following data is part of a premarket notification filed by Exactech, Inc. with the FDA for Novation Crown Cup Gxl Liners.
| Device ID | K100269 |
| 510k Number | K100269 |
| Device Name: | NOVATION CROWN CUP GXL LINERS |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | EXACTECH, INC. 2320 N.W. 66TH CT. Gainesville, FL 32653 |
| Contact | Graham L Cuthbert |
| Correspondent | Graham L Cuthbert 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 | 2010-01-29 |
| Decision Date | 2010-05-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885862037770 | K100269 | 000 |
| 10885862036810 | K100269 | 000 |
| 10885862036827 | K100269 | 000 |
| 10885862036834 | K100269 | 000 |
| 10885862036957 | K100269 | 000 |
| 10885862036964 | K100269 | 000 |
| 10885862036971 | K100269 | 000 |
| 10885862036988 | K100269 | 000 |
| 10885862037268 | K100269 | 000 |
| 10885862037275 | K100269 | 000 |
| 10885862037282 | K100269 | 000 |
| 10885862037299 | K100269 | 000 |
| 10885862037305 | K100269 | 000 |
| 10885862037428 | K100269 | 000 |
| 10885862037435 | K100269 | 000 |
| 10885862037442 | K100269 | 000 |
| 10885862037459 | K100269 | 000 |
| 10885862036803 | K100269 | 000 |