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Axis 130-45040

by Extremity Medical, LLC

Axis 130-45040 is a Class II device made by Extremity Medical, LLC, cleared under FDA 510(k) K171018 on 13 Jul 2017 and listed in FDA GUDID since 21 Jun 2019 (UDI-DI 00842078112595), active as of 22 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 22 Oct 2026

Documents

510(k) K171018

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00842078112595 UDI-DI Date21 Jun 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK171018 Date13 Jul 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K171018 decided 13 Jul 2017 Active
  • FDA GUDID UDI-DI 00842078112595 listed 21 Jun 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K171018
  2. Listed FDA GUDID 00842078112595

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Axis
Generic name
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Model / reference
130-45040
Primary DI / UDI-DI
00842078112595
510(k) Number
FDA product code
HWC
GMDN term
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Device class
Class II
Regulation number
888.3040
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Orthopaedic bone screw, non-bioabsorbable, non-sterile

Cleared under the same submission (K171018)

and 8 more cleared under K171018

Similar devices in this category

Other devices filed under Orthopaedic bone screw, non-bioabsorbable, non-sterile.

Other devices from Extremity Medical, LLC

See all devices from Extremity Medical, LLC →

Properties

  • Sterilise before use
  • Single use
  • Prescription use
  • Lot / batch number
Other properties (11, all answered No)