The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Posterior Stabilized Apollo Knee System.
| Device ID | K935789 |
| 510k Number | K935789 |
| Device Name: | POSTERIOR STABILIZED APOLLO KNEE SYSTEM |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Contact | Joann Ringer |
| Correspondent | Joann Ringer INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-06 |
| Decision Date | 1995-02-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024262478 | K935789 | 000 |