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Talos® (ha) Ibf

FDA UDI

Class II (US FDA UDI)

by Meditech Spine, Llc

Identity

Trade Name
TALOS® (HA) IBF FDA UDI
Generic Name
Surgical implant/trial-implant/sizer holder, reusable FDA UDI
Model / Reference
613-270119-07 FDA UDI

Identifiers

Primary DI / UDI-DI
B167613270119070 FDA UDI
510(k) Number
K170395 FDA UDI
FDA Product Code
MAX FDA UDI
GMDN Term
Surgical implant/trial-implant/sizer holder, 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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Surgical implant/trial-implant/sizer holder, reusable

Talos® (ha) Ibf by Meditech Spine, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical implant/trial-implant/sizer holder, reusable.

Cleared under the same submission

K170395 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Meditech Spine, Llc

Sources (1)

  • FDA UDI 6796d513-6145-4b1f-9938-15587e1788eb 33 fields · synced May 30, 2026