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Xmcp 102-40022

by Extremity Medical, LLC

Xmcp 102-40022 is a Class II device made by Extremity Medical, LLC, cleared under FDA 510(k) K121417 on 18 Jul 2012 and listed in FDA GUDID since 14 Feb 2017 (UDI-DI M78010240022), 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) K121417

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 NumberM78010240022 UDI-DI Date14 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK121417 Date18 Jul 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121417 decided 18 Jul 2012 Active
  • FDA GUDID UDI-DI M78010240022 listed 14 Feb 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K121417
  2. Listed FDA GUDID M78010240022

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Xmcp
Generic name
Orthopaedic bone screw, non-bioabsorbable, non-sterile
Model / reference
102-40022
Primary DI / UDI-DI
M78010240022
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

Similar devices in this category

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

Other devices from Extremity Medical, LLC

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Properties

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