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IntraOp Alignment System

FDA UDI

Class II (US FDA UDI)

by Alphatec Spine, Inc.

Identity

Trade Name
IntraOp Alignment System FDA UDI
Generic Name
Orthopaedic/craniofacial implantation planning software FDA UDI
Device Name
IntraOp Alignment System FDA UDI
Model / Reference
AIX4104 FDA UDI
Description
IntraOp Alignment System FDA UDI

Identifiers

Primary DI / UDI-DI
00190376525921 FDA UDI
510(k) Number
K240199 FDA UDI
FDA Product Code
JAA FDA UDI
LLZ FDA UDI
OWB FDA UDI
GMDN Term
Orthopaedic/craniofacial implantation planning software FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1650 FDA UDI
892.2050 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: Orthopaedic/craniofacial implantation planning software

IntraOp Alignment System by Alphatec Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic/craniofacial implantation planning software.

Cleared under the same submission

K240199 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Alphatec Spine, Inc.

Sources (1)

  • FDA UDI 1d7eb47c-a67a-4edd-9782-1f7534a157cf 35 fields · synced Jun 8, 2026