The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Hatric, 6&7mm, 9&10mm, 11&12mm, 14&15mm, Models Ar-13000b-07, -10, -12, -15.
| Device ID | K040381 |
| 510k Number | K040381 |
| Device Name: | HATRIC, 6&7MM, 9&10MM, 11&12MM, 14&15MM, MODELS AR-13000B-07, -10, -12, -15 |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Contact | Sally Foust |
| Correspondent | Sally Foust ARTHREX, INC. 1370 CREEKSIDE BLVD. Naples, FL 34108 -1945 |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-17 |
| Decision Date | 2004-05-12 |
| Summary: | summary |