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SpineAR SNAP

FDA UDI

Class II (US FDA UDI)

by Surgical Theater Llc

Identity

Trade Name
SpineAR SNAP FDA UDI
Generic Name
Surgical planning/navigation-enhancement system FDA UDI
Device Name
SpineAR Surgical Navigation Advanced Platform (SNAP) Operating Room System FDA UDI
Model / Reference
SpineAR FDA UDI
Description
SpineAR Surgical Navigation Advanced Platform (SNAP) Operating Room System FDA UDI

Identifiers

Primary DI / UDI-DI
00860003884126 FDA UDI
510(k) Number
K213034 FDA UDI
FDA Product Code
LLZ FDA UDI
OLO FDA UDI
GMDN Term
Surgical planning/navigation-enhancement system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.2050 FDA UDI
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

No

FDA UDI

Category: Surgical planning/navigation-enhancement system

SpineAR SNAP by Surgical Theater Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical planning/navigation-enhancement system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgical Theater Llc

Sources (1)

  • FDA UDI a3d77fe4-79f6-4648-8aa4-7b0bc5a7b5a0 35 fields · synced Jun 1, 2026