The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Highly Cross-linked Vitamin E Uhmwpe Tibial Inserts.
| Device ID | K103223 |
| 510k Number | K103223 |
| Device Name: | HIGHLY CROSS-LINKED VITAMIN E UHMWPE TIBIAL INSERTS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer + Additive/metal/polymer + Additive |
| Applicant | ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Contact | Albert E Alonso |
| Correspondent | Albert E Alonso ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758 |
| Product Code | OIY |
| Subsequent Product Code | JWH |
| Subsequent Product Code | MBH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-01 |
| Decision Date | 2010-12-21 |
| Summary: | summary |