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 |