The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Modular Oncology System Technology (most).
| Device ID | K960626 |
| 510k Number | K960626 |
| Device Name: | MODULAR ONCOLOGY SYSTEM TECHNOLOGY (MOST) |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented |
| Applicant | INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Jacqueline Hughes |
| Correspondent | Jacqueline Hughes 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 | 1996-02-13 |
| Decision Date | 1996-04-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024247758 | K960626 | 000 |