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 |