The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Natural-knee Tibial And Femoral Spacers.
| Device ID | K915240 |
| 510k Number | K915240 |
| Device Name: | NATURAL-KNEE TIBIAL AND FEMORAL SPACERS |
| Classification | Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer |
| Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Contact | J. D Webb |
| Correspondent | J. D Webb INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Product Code | HSX |
| CFR Regulation Number | 888.3520 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-21 |
| Decision Date | 1992-01-31 |