The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Natural-knee(r)/apollo(tm) Knee.
| Device ID | K935523 |
| 510k Number | K935523 |
| Device Name: | NATURAL-KNEE(R)/APOLLO(TM) KNEE |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | INTERMEDICS ORTHOPEDICS 1300-C EAST ANDERSON LN. Austin, TX 78752 |
| Contact | Joann Ringer |
| Correspondent | Joann Ringer INTERMEDICS ORTHOPEDICS 1300-C EAST ANDERSON LN. Austin, TX 78752 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-11-18 |
| Decision Date | 1995-06-06 |