The following data is part of a premarket notification filed by United Orthopedic Corporation with the FDA for Conformity Stem.
| Device ID | K183312 |
| 510k Number | K183312 |
| Device Name: | Conformity Stem |
| 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 30075 |
| Contact | Lois Ho |
| Correspondent | Lois Ho United Orthopedic Corporation No 57, Park Ave 2, Science Park Hsinchu, TW 30075 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-29 |
| Decision Date | 2019-08-08 |