Talos® Ibf

FDA UDI

Class II (US FDA UDI)

by Meditech Spine, Llc

Identity

Trade Name: TALOS® IBF FDA UDI
Generic Name: Polymeric spinal fusion cage, sterile FDA UDI
Model / Reference: 4-181850 FDA UDI

Identifiers

Primary DI / UDI-DI: B16741818500 FDA UDI
510(k) Number: K090707 FDA UDI
K150788 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Polymeric spinal fusion cage, sterile 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

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Polymeric spinal fusion cage, sterile

A comprehensive Polymeric spinal fusion cage, designed to fuse segments of the spine to treat anatomical abnormalities of the vertebrae. Made from non-bioabsorbable synthetic polymer, it is implanted between bone grafts or bones to provide mechanical stability.

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Avenue T — Ldr Spine USA · Class II
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VertebraLINK MI — LINKSPINE, INC. · Class I
ENCLAVE ANTERIOR SPINAL SYSTEM — BIOMET SPINE LLC · Class II

Cleared under the same submission

K090707 also covers:

K150788 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Meditech Spine, Llc

Sources (1)

FDA UDI 8a84b760-4d38-4be6-b356-2cdd29af8326 33 fields · synced Jul 18, 2026