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Tyber Medical

FDA UDI

Class II (US FDA UDI)

by Tyber Medical

Identity

Trade Name
Tyber Medical FDA UDI
Generic Name
Polymeric osteotomy fusion cage, non-customized FDA UDI
Device Name
ANTERIOR INSERTER 6" FDA UDI
Model / Reference
35-00000121 FDA UDI
Description
ANTERIOR INSERTER 6" FDA UDI

Identifiers

Catalog Number
35-00000121 FDA UDI
Primary DI / UDI-DI
M69535000001210 FDA UDI
510(k) Number
K171327 FDA UDI
FDA Product Code
HWC FDA UDI
HRS FDA UDI
PLF FDA UDI
GMDN Term
Polymeric osteotomy fusion cage, non-customized FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 FDA UDI
888.3030 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: Polymeric osteotomy fusion cage, non-customized

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

Similar devices

Also classified as Polymeric osteotomy fusion cage, non-customized.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Tyber Medical

Sources (1)

  • FDA UDI c784d1be-fc47-4167-8b0e-382fbfc4b9df 36 fields · synced May 30, 2026