The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Arthroscope.
| Device ID | K921119 |
| 510k Number | K921119 |
| Device Name: | ARTHREX ARTHROSCOPE |
| Classification | Arthroscope |
| Applicant | ARTHREX, INC. 3050 NORTH HORSESHOE DR. SUITE 200 Naples, FL 33942 |
| Contact | Don Grafton |
| Correspondent | Don Grafton ARTHREX, INC. 3050 NORTH HORSESHOE DR. SUITE 200 Naples, FL 33942 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-09 |
| Decision Date | 1994-04-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888867100497 | K921119 | 000 |
| 00888867028951 | K921119 | 000 |