The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for The Natural-knee Revision.
| Device ID | K930554 |
| 510k Number | K930554 |
| Device Name: | THE NATURAL-KNEE REVISION |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C Austin, TX 78752 |
| Contact | Joann Ringer |
| Correspondent | Joann Ringer INTERMEDICS ORTHOPEDICS 1300 EAST ANDERSON LN. BUILDING C 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 | 1993-02-03 |
| Decision Date | 1993-09-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024449589 | K930554 | 000 |