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PolyLock Midfoot TN-TR-0084

by Fusion Orthopedics, LLC

PolyLock Midfoot TN-TR-0084 is a Class I device made by Fusion Orthopedics, LLC, cleared under FDA 510(k) K211843 on 4 Mar 2022 and listed in FDA GUDID since 22 Dec 2025 (UDI-DI 00840124525115), 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 Number00840124525115 UDI-DI Date22 Dec 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 00840124525115 listed 22 Dec 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K211843
  2. Listed FDA GUDID 00840124525115

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  • Withdrawn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
Instrument tray, reusable
Model / Ref / Catalog
TN-TR-0084
Primary DI / UDI-DI
00840124525115
510(k) Number
FDA product code
OJH
GMDN term
Instrument tray, reusable
Device class
Class I
Regulation number
878.4800
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 OJH (Orthopedic Tray).

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
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)