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PolyLock Midfoot TN-CA-2002

by Fusion Orthopedics, LLC

PolyLock Midfoot TN-CA-2002 is a Class II device made by Fusion Orthopedics, LLC, cleared under FDA 510(k) K211843 on 4 Mar 2022 and listed in FDA GUDID since 2 Oct 2025 (UDI-DI 00840124521803), 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

510(k) K211843

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00840124521803 UDI-DI Date2 Oct 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK211843 Date4 Mar 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K211843 decided 4 Mar 2022 Active
  • FDA GUDID UDI-DI 00840124521803 listed 2 Oct 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K211843
  2. Listed FDA GUDID 00840124521803

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PolyLock Midfoot
Generic name
Custom-made orthopaedic/craniofacial surgical guide
Model / Ref / Catalog
TN-CA-2002
Primary DI / UDI-DI
00840124521803
510(k) Number
FDA product code
PBF
GMDN term
Custom-made orthopaedic/craniofacial surgical guide
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K211843)

and 8 more cleared under K211843

Similar devices

Other devices filed under FDA product code PBF (Orthopaedic Surgical Planning And Instrument Guides).

Other devices from Fusion Orthopedics USA, LLC

  • FibFix FN-TH-4713-S

    Class II

  • FibFix FN-TH-4713

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