The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Linear Porous Coated Hip Stem, Size 5; Revelation Hip Stem, Size 8; Foundation Porous Press Fit Stem, Size 8;.
| Device ID | K121024 |
| 510k Number | K121024 |
| Device Name: | LINEAR POROUS COATED HIP STEM, SIZE 5; REVELATION HIP STEM, SIZE 8; FOUNDATION POROUS PRESS FIT STEM, SIZE 8; |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | William Garzon |
| Correspondent | William Garzon ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | LPH |
| Subsequent Product Code | JDG |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-04 |
| Decision Date | 2012-06-19 |
| Summary: | summary |