The following data is part of a premarket notification filed by Intermedics Orthopedics with the FDA for Natural-knee Ii Unicompartmentalknee System.
| Device ID | K955778 |
| 510k Number | K955778 |
| Device Name: | NATURAL-KNEE II UNICOMPARTMENTALKNEE SYSTEM |
| Classification | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, 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 | HRY |
| CFR Regulation Number | 888.3530 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-20 |
| Decision Date | 1996-03-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00889024249059 | K955778 | 000 |
| 00889024249042 | K955778 | 000 |
| 00889024249035 | K955778 | 000 |
| 00889024249028 | K955778 | 000 |
| 00889024249011 | K955778 | 000 |
| 00889024249004 | K955778 | 000 |
| 00889024248991 | K955778 | 000 |
| 00889024248984 | K955778 | 000 |
| 00889024248977 | K955778 | 000 |