The following data is part of a premarket notification filed by Bonebridge Ag with the FDA for Salgina 2.5mm Volar Distal Radius System, Cascella 3.5mm Superior Clavicle System, Tamlna 3.5mm Proximal Humerus System, Trift 3.5mm 1/3 Tubular System.
| Device ID | K203002 |
| 510k Number | K203002 |
| Device Name: | SALGINA 2.5mm Volar Distal Radius System, CASCELLA 3.5mm Superior Clavicle System, TAMlNA 3.5mm Proximal Humerus System, TRIFT 3.5mm 1/3 Tubular System |
| Classification | Plate, Fixation, Bone |
| Applicant | Bonebridge AG Bahnhofstrasse 11 Zug, CH 6300 |
| Contact | Christof Gerber |
| Correspondent | Sandra Soniec meditec Consulting GmbH Obermoosstrasse 23 Boll, CH 3067 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-01 |
| Decision Date | 2021-10-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640187461442 | K203002 | 000 |
| 07640187461077 | K203002 | 000 |
| 07640187461060 | K203002 | 000 |
| 07640187461053 | K203002 | 000 |
| 07640187461046 | K203002 | 000 |
| 07640187461039 | K203002 | 000 |
| 07640187461008 | K203002 | 000 |
| 07640187460995 | K203002 | 000 |
| 07640187460988 | K203002 | 000 |
| 07640187460971 | K203002 | 000 |
| 07640187460964 | K203002 | 000 |
| 07640187461107 | K203002 | 000 |
| 07640187461022 | K203002 | 000 |
| 07640187461084 | K203002 | 000 |
| 07640187461091 | K203002 | 000 |
| 07640187461114 | K203002 | 000 |
| 07640187461435 | K203002 | 000 |
| 07640187461428 | K203002 | 000 |
| 07640187461411 | K203002 | 000 |
| 07640187461404 | K203002 | 000 |
| 07640187461398 | K203002 | 000 |
| 07640187461183 | K203002 | 000 |
| 07640187461176 | K203002 | 000 |
| 07640187461169 | K203002 | 000 |
| 07640187461152 | K203002 | 000 |
| 07640187461145 | K203002 | 000 |
| 07640187461138 | K203002 | 000 |
| 07640187461121 | K203002 | 000 |
| 07640187461015 | K203002 | 000 |