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Holo

FDA UDI

Class II (US FDA UDI)

by Surgalign Spine Technologies

Identity

Trade Name
HOLO FDA UDI
Generic Name
Optical surgical navigation device tracking system FDA UDI
Device Name
HOLO Patient Array FDA UDI
Model / Reference
154000412 FDA UDI
Description
HOLO Patient Array FDA UDI

Identifiers

Primary DI / UDI-DI
00850028694633 FDA UDI
510(k) Number
K211254 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

No

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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Optical surgical navigation device tracking system

Holo by Surgalign Spine Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Optical surgical navigation device tracking system.

Cleared under the same submission

K211254 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Surgalign Spine Technologies

Sources (1)

  • FDA UDI 0bcda095-0832-4d57-9dd3-1077d281139b 35 fields · synced Jun 8, 2026