The following data is part of a premarket notification filed by Biomet Orthopedics, Inc. with the FDA for Innervue Diagnostic Scope System.
| Device ID | K072879 |
| 510k Number | K072879 |
| Device Name: | INNERVUE DIAGNOSTIC SCOPE SYSTEM |
| Classification | Arthroscope |
| Applicant | BIOMET ORTHOPEDICS, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Contact | Susan Alexander |
| Correspondent | Susan Alexander BIOMET ORTHOPEDICS, INC. 56 EAST BELL DR. P.O. BOX 587 Warsaw, IN 46581 -0587 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-09 |
| Decision Date | 2008-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00880304475861 | K072879 | 000 |