The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Natural Hip System - Drg Hip Stem.
| Device ID | K961799 |
| 510k Number | K961799 |
| Device Name: | NATURAL HIP SYSTEM - DRG HIP STEM |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Sam Mirza |
| Correspondent | Sam Mirza INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | JDI |
| CFR Regulation Number | 888.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-09 |
| Decision Date | 1996-07-15 |
| Summary: | summary |