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 |