The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for Locking Cage, Full Xpe Cup.
| Device ID | K163441 |
| 510k Number | K163441 |
| Device Name: | Locking Cage, Full XPE Cup |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | UNITED ORTHOPEDIC CORPORATION NO 57, PARK AVE 2, SCIENCE PARK Hsinchu, TW 300 |
| Contact | Gimpel Chien |
| Correspondent | Gimpel Chien UNITED ORTHOPEDIC CORPORATION NO 57, PARK AVE 2, SCIENCE PARK Hsinchu, TW 300 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-08 |
| Decision Date | 2017-08-25 |