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Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left
FDA UDIClass II (US FDA UDI)
Identity
- Trade Name
- Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left FDA UDI
- Generic Name
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
- Model / Reference
- 20-8090-004-01 FDA UDI
Identifiers
- Catalog Number
- 20-8090-004-01 FDA UDI
- Primary DI / UDI-DI
- 00889024563391 FDA UDI
- 510(k) Number
- K190595 FDA UDI
- FDA Product Code
- QHE FDA UDI
- GMDN Term
- Orthopaedic prosthesis implantation positioning instrument, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Orthopaedic prosthesis implantation positioning instrument, single-use
Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Left by Orthosoft Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic prosthesis implantation positioning instrument, single-use.
- MyKnee PPS — Medacta International · Class II
- MyKnee — Medacta International · Class II
- MyKnee PPS — Medacta International · Class II
- MyKnee — Medacta International · Class II
- MyKnee — Medacta International · Class II
- My Knee Tibial Cutting Blocks MIS — Medacta International · Class II
- My Spine Low Profile Placement Guides — Medacta International · Class II
- MySpine Unilateral Guide — Medacta International · Class II
Cleared under the same submission
K190595 also covers:
- Comprehensive® Reverse Shoulder Augmented Guide and Bone Model Right — Orthosoft Inc
- Comprehensive® Reverse Shoulder Mini Guide and Bone Model Left — Orthosoft Inc
- Comprehensive® Reverse Shoulder Mini Guide and Bone Model Right — Orthosoft Inc
- Comprehensive® Total Shoulder Guide and Bone Model Left — Orthosoft Inc
- Comprehensive® Total Shoulder Guide and Bone Model Right — Orthosoft Inc
- Shoulder Bone Model Only 2.5mm Pin — Orthosoft Inc
- Shoulder Bone Model Only 3.2mm Pin — Orthosoft Inc
- Shoulder Pure Planning — Orthosoft Inc
- Signature ONE Software Package — Orthosoft Inc
- Signature ONE Software Package — Orthosoft Inc
- Signature ONE Software Package — Orthosoft Inc
- TMR+™ Shoulder Guide and Bone Model Left — Orthosoft Inc
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Orthosoft Inc
Sources (1)
- FDA UDI 3ec7b966-75ca-4638-9cfc-4017f0adb9f8 35 fields · synced Jun 1, 2026