The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Revelation Porous Coated Hip Stem, Size 8.
| Device ID | K122636 |
| 510k Number | K122636 |
| Device Name: | REVELATION POROUS COATED HIP STEM, SIZE 8 |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Teffany Hutto |
| Correspondent | Teffany Hutto ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | LPH |
| Subsequent Product Code | KWZ |
| Subsequent Product Code | LZO |
| Subsequent Product Code | MBL |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-29 |
| Decision Date | 2012-11-02 |
| Summary: | summary |