The following data is part of a premarket notification filed by Arthrex, Inc. with the FDA for Bi-cortical Bio Post And Washer, Model Ar-1367b.
| Device ID | K023119 |
| 510k Number | K023119 |
| Device Name: | BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B |
| Classification | Washer, Bolt Nut |
| Applicant | ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Contact | Ann Waterhouse |
| Correspondent | Ann Waterhouse ARTHREX, INC. 2885 SOUTH HORSESHOE DR. Naples, FL 34104 |
| Product Code | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-19 |
| Decision Date | 2002-12-18 |
| Summary: | summary |