Skip to content

Mayfield® 421A1117

by Integra Lifesciences Corp.

Mayfield® 421A1117 is a Class II device made by Integra Lifesciences Corp., cleared under FDA 510(k) K051440 on 20 Sep 2005 and listed in FDA GUDID since 26 Jul 2016 (UDI-DI 10381780254362), 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) K051440

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 Number10381780254362 UDI-DI Date26 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK051440 Date20 Sep 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K051440 decided 20 Sep 2005 Active
  • FDA GUDID UDI-DI 10381780254362 listed 26 Jul 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K051440
  2. Listed FDA GUDID 10381780254362

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  • Withdrawn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
421A1117
Primary DI / UDI-DI
10381780254362
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
MRI safety
MR Unsafe

Related devices

Category: Skull clamp

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)