OptiVu Shoulder Adapter Handle - Universal adapter handle for use with pin inserter and cut guide.
2026-06-03
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3043520095 | 3043520095 | MR SURGICAL SOLUTIONS, LLC | 1 | N | 2026-01-01 | Bubenbergstrasse 1 3rd Floor Zurich CH 8045 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00850084604010 | OptiVu Shoulder Pin Inserter - Pin inserter for glenoid Steinmann pin placement | +41445525264 | admin@fixsurgical.com |
| 00850084604027 | OptiVu Shoulder Cut Guide - Cut guide for establishing the humeral resection plane | +41445525264 | admin@fixsurgical.com |
| 00850084604034 | OptiVu Shoulder Stylus - Stylus used to register three dimensional shoulder anatomy | +41445525264 | admin@fixsurgical.com |
| 00850084604041 | OptiVu Shoulder Reaming Guide - Reaming guide used to assist in determining glenoid ream depth | +41445525264 | admin@fixsurgical.com |
| 00850084604058 | OptiVu Shoulder Clocking Guide - Clocking guide used to align the glenoid implant to the planned rotation | +41445525264 | admin@fixsurgical.com |
| 00850084604072 | OptiVu Shoulder Scapular Reference Rod - Scapula reference rod that attaches to the coracoid to provide a tracking reference | +41445525264 | admin@fixsurgical.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 347618 | 1034155656 | K252530 | OptiVu™ Shoulder | SBF | 2025-09-10 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| SBF | 1 | 2025-09-10 |
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