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Mayfield® GS422

by Integra Lifesciences Corp.

Mayfield® GS422 is a Class II device made by Integra Lifesciences Corp., cleared under FDA 510(k) K120633 on 24 May 2012 (5 earlier submissions) and listed in FDA GUDID since 2 Aug 2016 (UDI-DI 10381780256847), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10381780256847 UDI-DI Date2 Aug 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK120633 Date24 May 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K120633 decided 24 May 2012 Active· +5 more in the status table
  • FDA GUDID UDI-DI 10381780256847 listed 2 Aug 2016 Listed

Recalls

3 recalls · FDA

    • Terminated Z-0548-2021 FDA Class II initiated 11 Nov 2020

    Revised Instruction Manual to reflect the most accurate illustration for Mayfield Skull Clamp A2000 Position Diagram

    • Terminated Z-0210-2014 FDA Class II initiated 29 Aug 2013

    An investigation of an adverse trend of complaints for the Skull Clamp index locking knob not easily unlocking or disengaging and malfunctions of the 80 lbs. torque knob was initiated. None of the complaints resulted in a report of patient injury, adverse health consequence, or a delay / prolongation of the surgical procedure.

    • Terminated Z-0559-2013 FDA Class II initiated 5 Nov 2012

    An investigation of an adverse trend of complaints conducted by Integra LifeSciences identified various product performance issues which could impact the functionality of the firm's Mayfield Composite Series Base Units and Mayfield Skull Clamps. In order to prevent additional complaint reports, the firm decided to recall and replace certain lot codes of the Base Units and Skull Clamps that were d

Timeline

10 dated events

  1. Cleared FDA 510(k) K932807
  2. Cleared FDA 510(k) K953124
  3. Cleared FDA 510(k) K050319
  4. Cleared FDA 510(k) K051440
  5. Cleared FDA 510(k) K081401
  6. Cleared FDA 510(k) K120633
  7. Recall initiated FDA recalls Z-0559-2013
  8. Recall initiated FDA recalls Z-0210-2014
  9. Listed FDA GUDID 10381780256847
  10. Recall initiated FDA recalls Z-0548-2021

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mayfield®
Generic name
Skull clamp
Model / reference
GS422
Primary DI / UDI-DI
10381780256847
510(k) Number
FDA product code
HBL
GMDN term
Skull clamp
Device class
Class II
Regulation number
882.4460
GUDID distribution status
In Commercial Distribution

Related devices

Category: Skull clamp

Cleared under the same submission (K050319)

and 8 more cleared under K050319

Cleared under the same submission (K051440)

and 8 more cleared under K051440

Similar devices in this category

Other devices filed under Skull clamp.

Other devices from Integra Lifesciences Corp.

See all devices from Integra Lifesciences Corp. →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)