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Zavation

FDA UDI

Class II (US FDA UDI)

by Zavation

Identity

Trade Name
Zavation FDA UDI
Generic Name
Sacroiliac joint intra-articular arthrodesis implant FDA UDI
Device Name
Posterior Lateral Screw 12.5mmx35mm FDA UDI
Model / Reference
770-12535 FDA UDI
Description
Posterior Lateral Screw 12.5mmx35mm FDA UDI

Identifiers

Primary DI / UDI-DI
00197157004446 FDA UDI
510(k) Number
K173752 FDA UDI
FDA Product Code
OUR FDA UDI
HWC FDA UDI
GMDN Term
Sacroiliac joint intra-articular arthrodesis implant FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

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: Sacroiliac joint intra-articular arthrodesis implant

Zavation by Zavation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Sacroiliac joint intra-articular arthrodesis implant.

Cleared under the same submission

K173752 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 5ddc5888-891a-46ef-ae13-2e18cf5e660a 35 fields · synced Jun 6, 2026