The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Natural Hip System Porous Stem - Collarless, Collared.
| Device ID | K963266 |
| 510k Number | K963266 |
| Device Name: | NATURAL HIP SYSTEM POROUS STEM - COLLARLESS, COLLARED |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Jacquelyn A Hughes |
| Correspondent | Jacquelyn A 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 | 1996-08-20 |
| Decision Date | 1996-10-15 |
| Summary: | summary |