The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Acl Avulsion Lag Screw With Sheath Model Number Ar-6001.
| Device ID | K981187 |
| 510k Number | K981187 |
| Device Name: | ACL AVULSION LAG SCREW WITH SHEATH MODEL NUMBER AR-6001 |
| Classification | Screw, Fixation, Bone |
| Applicant | ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Contact | Scott M Durlacher |
| Correspondent | Scott M Durlacher ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-02 |
| Decision Date | 1998-07-01 |
| Summary: | summary |