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 |