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PolyLock Small Bone SB-TB-1000

by Fusion Orthopedics, LLC

PolyLock Small Bone SB-TB-1000 is a Class II device made by Fusion Orthopedics, LLC, listed in FDA GUDID since 1 Aug 2024 (UDI-DI 00840124513730), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840124513730 UDI-DI Date1 Aug 2024ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade name
PolyLock Small Bone
Generic name
Orthopaedic fixation plate, bioabsorbable
Model / Ref / Catalog
SB-TB-1000
Primary DI / UDI-DI
00840124513730
FDA product code
NDF
GMDN term
Orthopaedic fixation plate, bioabsorbable
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic fixation plate, bioabsorbable

Other devices from Fusion Orthopedics USA, LLC

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    Class II

  • FibFix FN-TH-5713

    Class II

  • FibFix FN-TH-5713-S

    Class II

See all devices from Fusion Orthopedics USA, LLC →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)