The following data is part of a premarket notification filed by Orthopaedic Biosystems, Ltd. with the FDA for Polymer Threaded Anchor.
| Device ID | K983169 |
| 510k Number | K983169 |
| Device Name: | POLYMER THREADED ANCHOR |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | ORTHOPAEDIC BIOSYSTEMS, LTD. 15990 N GREENWAY-HAYDEN LOOP SUITE 100 Scottsdale, AZ 85260 |
| Contact | Jeffry B Skiba |
| Correspondent | Jeffry B Skiba ORTHOPAEDIC BIOSYSTEMS, LTD. 15990 N GREENWAY-HAYDEN LOOP SUITE 100 Scottsdale, AZ 85260 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-10 |
| Decision Date | 1998-12-16 |
| Summary: | summary |