The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Natural-knee Ii Revision Femoral Spacer Lugs.
| Device ID | K970498 |
| 510k Number | K970498 |
| Device Name: | NATURAL-KNEE II REVISION FEMORAL SPACER LUGS |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
| Contact | Mitchell A Dhority |
| Correspondent | Mitchell A Dhority INTERMEDICS ORTHOPEDICS 9900 SPECTRUM DR. Austin, TX 78717 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-10 |
| Decision Date | 1997-04-30 |
| Summary: | summary |