The following data is part of a premarket notification filed by Apex Surgical, Llc. with the FDA for Apex Modular Zirconia Femoral Head.
| Device ID | K003923 |
| 510k Number | K003923 |
| Device Name: | APEX MODULAR ZIRCONIA FEMORAL HEAD |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| Applicant | APEX SURGICAL, LLC. 12 HARDING STREET,SUITE 202 Lakeville, MA 02347 |
| Contact | Edward J Cheal |
| Correspondent | Edward J Cheal APEX SURGICAL, LLC. 12 HARDING STREET,SUITE 202 Lakeville, MA 02347 |
| Product Code | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-12-20 |
| Decision Date | 2001-03-20 |