The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Arthrex Puddu Osteotomy System.
| Device ID | K973812 |
| 510k Number | K973812 |
| Device Name: | ARTHREX PUDDU OSTEOTOMY SYSTEM |
| Classification | Plate, 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 | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-07 |
| Decision Date | 1998-06-10 |
| Summary: | summary |