Identity
- Trade Name
- OnPoint Surgical Cart FDA UDI
- Generic Name
- Orthopaedic stereotactic surgery system FDA UDI
- Device Name
- OnPoint Surgical Cart (with pre-installed software) - 1 headset FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- OnPoint Surgical Cart (with pre-installed software) - 1 headset FDA UDI
Identifiers
- Catalog Number
- NK0210101 FDA UDI
- Primary DI / UDI-DI
- 00850051682010 FDA UDI
- FDA Product Code
- SBF FDA UDI
- GMDN Term
- Orthopaedic stereotactic surgery 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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthopaedic stereotactic surgery system
OnPoint Surgical Cart by OnPoint Surgical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic stereotactic surgery system.
- TRIGEN — Smith & Nephew, Inc. · Class II
- PULSE — Nuvasive, Inc. · Class II
- KneePlus — PIXEE MEDICAL · Class II
- intellijoint HIP® — Intellijoint Surgical Inc · Class II
- PULSE — Nuvasive, Inc. · Class II
- Navigation Unit Kit — GYDER SURGICAL PTY LTD · Class II
- StealthStation S8 Spine — MEDTRONIC NAVIGATION, INC. · Class II
- WatchTower — Intai Technology Corporation · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- OnPoint Surgical, Inc.
Sources (1)
- FDA UDI b54cb8bc-e0a5-480b-b5d5-a2ce38533395 35 fields · synced May 30, 2026