The following data is part of a premarket notification filed by Apex Surgical, Llc. with the FDA for Apex Modular Hip Stem.
| Device ID | K000788 |
| 510k Number | K000788 |
| Device Name: | APEX MODULAR HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | APEX SURGICAL, LLC. 39 TAUNTON GREEN, SUITE 202 Taunton, MA 02780 |
| Contact | Edward J Cheal |
| Correspondent | Edward J Cheal APEX SURGICAL, LLC. 39 TAUNTON GREEN, SUITE 202 Taunton, MA 02780 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-10 |
| Decision Date | 2000-08-04 |
| Summary: | summary |