The following data is part of a premarket notification filed by S.b.m. Sas (science & Bio Materials) with the FDA for 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 Liga.
| Device ID | K202193 |
| 510k Number | K202193 |
| Device Name: | 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 Liga |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | S.B.M. SAS (Science & Bio Materials) Zi Du Monge Lourdes, FR 65100 |
| Contact | Anne Cospin-latapie |
| Correspondent | Anne Cospin-latapie S.B.M. SAS (Science & Bio Materials) Zi Du Monge Lourdes, FR 65100 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-05 |
| Decision Date | 2020-10-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 03760154008945 | K202193 | 000 |
| 03760154008204 | K202193 | 000 |
| 03760154008198 | K202193 | 000 |