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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04711605586573 | K183312 | 000 |
| 04711605585354 | K183312 | 000 |
| 04711605587112 | K183312 | 000 |
| 04719886896176 | K183312 | 000 |
| 04719886896169 | K183312 | 000 |
| 04719886896152 | K183312 | 000 |
| 04719886896145 | K183312 | 000 |
| 04719886896138 | K183312 | 000 |
| 04719886896121 | K183312 | 000 |
| 04719886896114 | K183312 | 000 |
| 04719886896107 | K183312 | 000 |
| 04719886896091 | K183312 | 000 |
| 04719886896084 | K183312 | 000 |
| 04711605585361 | K183312 | 000 |
| 04711605585378 | K183312 | 000 |
| 04711605585385 | K183312 | 000 |
| 04711605587105 | K183312 | 000 |
| 04711605587099 | K183312 | 000 |
| 04711605587082 | K183312 | 000 |
| 04711605587075 | K183312 | 000 |
| 04711605586597 | K183312 | 000 |
| 04711605585453 | K183312 | 000 |
| 04711605585446 | K183312 | 000 |
| 04711605585439 | K183312 | 000 |
| 04711605585422 | K183312 | 000 |
| 04711605585415 | K183312 | 000 |
| 04711605585408 | K183312 | 000 |
| 04711605585392 | K183312 | 000 |
| 04719886896077 | K183312 | 000 |