The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for X-alt Highly Cross Linked Acetabular Liners With Vitamin E, Neutral, 10 Degree Hooded, 20 Degree Hooded.
| Device ID | K140130 |
| 510k Number | K140130 |
| Device Name: | X-ALT HIGHLY CROSS LINKED ACETABULAR LINERS WITH VITAMIN E, NEUTRAL, 10 DEGREE HOODED, 20 DEGREE HOODED |
| Classification | Hip Prosthesis, Semi-constrained, Cemented, Metal/polymer, + Additive, 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 | OQG |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-01-17 |
| Decision Date | 2014-11-06 |
| Summary: | summary |