Talos® Ha Peek Ibf

FDA UDI

Class II (US FDA UDI)

by Meditech Spine, Llc

Identity

Trade Name: TALOS® HA PEEK IBF FDA UDI
Generic Name: Polymeric spinal fusion cage, sterile FDA UDI
Model / Reference: 3-21611-12 FDA UDI

Identifiers

Primary DI / UDI-DI: B167321611120 FDA UDI
510(k) Number: K170395 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

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Manufacturing Date

FDA UDI

Category: Polymeric spinal fusion cage, sterile

TALOS HA PEEK IBF is a sterile, implantable polymeric spinal fusion cage used to fuse segments of the spine for treating anatomical abnormalities of the vertebrae. Designed as a small, hollow and/or porous cylinder made of non-bioabsorbable synthetic polymer (PEEK), it provides mechanical stability and sufficient space for bone fusion to occur. The device is typically fixed in place with fixation screws and associated devices.

Similar devices

Also classified as Polymeric spinal fusion cage, sterile.

ROCCIA — Silony Medical GmbH · Class II
TiNano — AURORA SPINE, INC. · Class II
EVOS Lumbar Interbody System — CUTTING EDGE SPINE · Class II
Aurora Spine — AURORA SPINE, INC. · Class II
Avenue T — Ldr Spine USA · Class II
EVOS Lumbar Interbody System — CUTTING EDGE SPINE · Class II
VertebraLINK MI — LINKSPINE, INC. · Class I
ENCLAVE ANTERIOR SPINAL SYSTEM — BIOMET SPINE LLC · Class II

Cleared under the same submission

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 b30687b6-5bbf-434b-8142-d21102d28aee 33 fields · synced Jul 8, 2026