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Mayfield® A1121

by Integra Lifesciences Corp.

Ref A1121

Mayfield® A1121 is a device classified as Class IIa in the EU and Class II in the US made by Integra Lifesciences Corp., registered in EUDAMED on 24 Sep 2026 (Basic UDI-DI B-10381780253631), cleared under FDA 510(k) K072208 on 7 Sep 2007 and listed in FDA GUDID since 26 Jul 2016 (UDI-DI 10381780253631), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K072208

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10381780253631 Basic UDI-DI 10381780253631UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780253631 UDI-DI Date26 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK072208 Date7 Sep 2007DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10381780253631 registered 24 Sep 2026 Active
  • FDA 510(k) K072208 decided 7 Sep 2007 Active
  • FDA GUDID UDI-DI 10381780253631 listed 26 Jul 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K072208
  2. Listed FDA GUDID 10381780253631
  3. Registered EUDAMED B-10381780253631

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Mayfield®
Generic name
Skull clamp
Device name
Skull Pins (Titanium)
Model / Ref / Catalog
A1121
Primary DI / UDI-DI
10381780253631
Basic UDI-DI
B-10381780253631
510(k) Number
FDA product code
HBL
EMDN code
L1199 Neurosurgery instruments, reusable - other
GMDN term
Skull clamp
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4460
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Skull clamp

Cleared under the same submission (K072208)

and 3 more cleared under K072208

Similar devices in this category

Other devices filed under NEUROSURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Integra Lifesciences Corp.

See all devices from Integra Lifesciences Corp. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)