The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Constrained Liner.
| Device ID | K023794 |
| 510k Number | K023794 |
| Device Name: | CONSTRAINED LINER |
| Classification | Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/polymer |
| Applicant | ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Debbie De Los Santos |
| Correspondent | Debbie De Los Santos ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | KWZ |
| CFR Regulation Number | 888.3310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-13 |
| Decision Date | 2003-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888912085663 | K023794 | 000 |
| 00888912085861 | K023794 | 000 |
| 00888912085878 | K023794 | 000 |
| 00888912085885 | K023794 | 000 |
| 00888912085908 | K023794 | 000 |
| 00888912085915 | K023794 | 000 |
| 00888912085687 | K023794 | 000 |
| 00888912085694 | K023794 | 000 |
| 00888912085700 | K023794 | 000 |
| 00888912085717 | K023794 | 000 |
| 00888912085731 | K023794 | 000 |
| 00888912085755 | K023794 | 000 |
| 00888912085762 | K023794 | 000 |
| 00888912085779 | K023794 | 000 |
| 00888912085854 | K023794 | 000 |