K202193 is an FDA 510(k) clearance for the PULLUP BTB Adjustable Fixation System for Ligament Reconstruction, PULLUP CLIP Adjustable Fixation System for Ligament Reconstruction, PULLUP TEX CLIP Adjustable Fixation System for Ligament Reconstruction, BT LOOP Adjustable Fixation System for Ligament Reconstruction. This device is classified as a Fastener, Fixation, Nondegradable, Soft Tissue (Class II - Special Controls, product code MBI).
Submitted by S.B.M. Sas (Science & Bio Materials) (Lourdes, FR). The FDA issued a Cleared decision on October 16, 2020, 72 days after receiving the submission on August 5, 2020.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.3040.
| 510(k) Number | K202193 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 05, 2020 |
| Decision Date | October 16, 2020 |
| Days to Decision | 72 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | MBI - Fastener, Fixation, Nondegradable, Soft Tissue |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.3040 |