Identity
- Trade Name
- NextAR Spine Platform FDA UDI
- Generic Name
- Optical surgical navigation device tracking system FDA UDI
- Device Name
- NextAR Spine tap aggressive undersize Ø6 FDA UDI
- Model / Reference
- 03.57.10.0154 FDA UDI
- Description
- NextAR Spine tap aggressive undersize Ø6 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 07630345729125 FDA UDI
- 510(k) Number
- K210859 FDA UDI
- FDA Product Code
- OLO FDA UDI
- GMDN Term
- Optical surgical navigation device tracking system 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Optical surgical navigation device tracking system
NextAR Spine Platform by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K210859 also covers:
- NextAR Spine Platform — Medacta International
- NextAR Spine Platform — Medacta International
- NextAR Spine Platform — Medacta International
- NextAR Spine Platform — Medacta International
- NextAR Spine Platform — Medacta International
- NextAR Spine Platform — Medacta International
- NextAR Spine Platform — Medacta International
- NextAR Spine Platform — Medacta International
- NextAR Spine Platform — Medacta International
- NextAR Spine Platform — Medacta International
- NextAR Spine Platform — Medacta International
- NextAR Spine 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 d61efe0a-1eb1-41c8-b4b7-3faf597c59ad 34 fields · synced May 31, 2026