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Talos® Ibf 1-100930

by Meditech Spine, LLC

Talos® Ibf 1-100930 is a Class II device made by Meditech Spine, LLC, cleared under FDA 510(k) K150788 on 14 Oct 2015 (1 earlier submission) and listed in FDA GUDID since 20 Sep 2016 (UDI-DI B16711009300), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberB16711009300 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK150788 Date14 Oct 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K150788 decided 14 Oct 2015 Active· +1 more in the status table
  • FDA GUDID UDI-DI B16711009300 listed 20 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K090707
  2. Cleared FDA 510(k) K150788
  3. Listed FDA GUDID B16711009300

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Talos® Ibf
Generic name
Polymeric spinal fusion cage, sterile
Model / reference
1-100930
Primary DI / UDI-DI
B16711009300
510(k) Number
FDA product code
MAX
GMDN term
Polymeric spinal fusion cage, sterile
Device class
Class II
Regulation number
888.3080
GUDID distribution status
In Commercial Distribution

Related devices

Category: Polymeric spinal fusion cage, sterile

Cleared under the same submission (K090707)

and 8 more cleared under K090707

Cleared under the same submission (K150788)

and 8 more cleared under K150788

Other devices from Meditech Spine, LLC

See all devices from Meditech Spine, LLC →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)