The following data is part of a premarket notification filed by Hospital For Special Surgery with the FDA for Insall-burstein Ii.
Device ID | K935080 |
510k Number | K935080 |
Device Name: | INSALL-BURSTEIN II |
Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
Applicant | HOSPITAL FOR SPECIAL SURGERY 535 EAST 70 ST. New York, NY 10021 |
Contact | Bruce H Robie |
Correspondent | Bruce H Robie HOSPITAL FOR SPECIAL SURGERY 535 EAST 70 ST. New York, NY 10021 |
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 | 1993-10-25 |
Decision Date | 1995-05-22 |