Identity
- Trade Name
- NextAR (TM) Shoulder Platform FDA UDI
- Generic Name
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
- Device Name
- NextAR GRS central screw tap - ZH FDA UDI
- Model / Reference
- 04.01.10.0907 FDA UDI
- Description
- NextAR GRS central screw tap - ZH FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630542765391 FDA UDI
- 510(k) Number
- K251737 FDA UDI
- FDA Product Code
- SBF FDA UDI
- GMDN Term
- Orthopaedic surgical procedure kit, non-medicated, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.4560 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
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 surgical procedure kit, non-medicated, reusable
NextAR (TM) Shoulder Platform by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic surgical procedure kit, non-medicated, reusable.
- Arthrex® — Arthrex, Inc. · Class I
- RAZEK EQUIPAMENTOS — RAZEK EQUIPAMENTOS LTDA · Class I
- General Instruments — ORTHOPEDIATRICS CORP. · Class I
- ORTHOPEDIC MANUAL SURGICAL INSTRUMENT — FX SOLUTIONS · Class I
- CREO — GLOBUS MEDICAL, INC. · Class II
- Spine Instruments — GBS Commonwealth Co., Ltd. · Class I
- MADISON — Implanet · Class I
- NAVIGATION INSTRUMENTS — GLOBUS MEDICAL, INC. · Class II
Cleared under the same submission
K251737 also covers:
- NextAR (TM) Shoulder Platform — Medacta International
- NextAR (TM) Shoulder Platform — Medacta International
- NextAR (TM) Shoulder Platform — Medacta International
- NextAR (TM) Shoulder Platform — Medacta International
- NextAR (TM) Shoulder Platform — Medacta International
- NextAR (TM) Shoulder Platform — Medacta International
- NextAR (TM) Shoulder Platform — Medacta International
- NextAR (TM) Shoulder Platform — Medacta International
- NextAR (TM) Shoulder Platform — Medacta International
- NextAR (TM) Shoulder Platform — Medacta International
- NextAR (TM) Shoulder Platform — Medacta International
- NextAR (TM) Shoulder Platform — Medacta International
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
- Medacta International
Sources (1)
- FDA UDI 30f9c6a5-832c-485b-ad4d-3ae91b0e6f5d 34 fields · synced May 30, 2026