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Zavation VariSync ALIF Universal Freehand Cage Inserter

FDA UDI

Class II (US FDA UDI)

by Zavation

Identity

Trade Name
Zavation VariSync ALIF Universal Freehand Cage Inserter FDA UDI
Generic Name
Internal spinal fixation procedure kit, reusable FDA UDI
Device Name
VariSync ALIF Universal Freehand Cage Inserter FDA UDI
Model / Reference
869-1036 FDA UDI
Description
VariSync ALIF Universal Freehand Cage Inserter FDA UDI

Identifiers

Primary DI / UDI-DI
00197157029319 FDA UDI
510(k) Number
K230731 FDA UDI
FDA Product Code
ODP FDA UDI
MAX FDA UDI
GMDN Term
Internal spinal fixation procedure kit, reusable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Internal spinal fixation procedure kit, reusable

Zavation VariSync ALIF Universal Freehand Cage Inserter by Zavation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Internal spinal fixation procedure kit, reusable.

Cleared under the same submission

K230731 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zavation

Sources (1)

  • FDA UDI 1e2a1804-e684-4033-bafe-1bece61435ca 35 fields · synced Jun 1, 2026