The following data is part of a premarket notification filed by Acumed, Inc. with the FDA for Acumed Suture Anchor.
| Device ID | K980103 |
| 510k Number | K980103 |
| Device Name: | ACUMED SUTURE ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Contact | Shari Jeffers |
| Correspondent | Shari Jeffers ACUMED, INC. 10950 S.W. 5TH ST. SUITE 170 Beaverton, OR 97005 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-12 |
| Decision Date | 1998-03-16 |
| Summary: | summary |