The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Modular Acetabular Shell Ii.
| Device ID | K955739 |
| 510k Number | K955739 |
| Device Name: | MODULAR ACETABULAR SHELL II |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Jacquelyn Hughes |
| Correspondent | Jacquelyn Hughes INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | LPH |
| CFR Regulation Number | 888.3358 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-18 |
| Decision Date | 1996-03-27 |
| Summary: | summary |