The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Video Arthroscope, Models Ar-3050-30, Ar-3050t-30, Ar-3050-70, Ar-3051-30, Ar-3052-30, Ar3030an, Ar-3030as, Ar3030aw.
| Device ID | K030096 |
| 510k Number | K030096 |
| Device Name: | VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW |
| Classification | Arthroscope |
| Applicant | ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Contact | Sally Foust |
| Correspondent | Sally Foust ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-10 |
| Decision Date | 2003-03-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00888867028845 | K030096 | 000 |
| 00888867029033 | K030096 | 000 |
| 00888867029064 | K030096 | 000 |
| 00888867029149 | K030096 | 000 |
| 00888867100398 | K030096 | 000 |
| 00888867100428 | K030096 | 000 |
| 00888867194595 | K030096 | 000 |
| 00888867194601 | K030096 | 000 |
| 00888867194618 | K030096 | 000 |
| 00888867028302 | K030096 | 000 |