Skip to content

Mayfield® A1083

by Integra Lifesciences Corp.

Ref A1083

Mayfield® A1083 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-10381780025788), cleared under FDA 510(k) K932860 on 28 Sep 1993 and listed in FDA GUDID since 26 Jul 2016 (UDI-DI 10381780025788), 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) K932860

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-10381780025788 Basic UDI-DI 10381780025788UDI-DIDate24 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10381780025788 UDI-DI Date26 Jul 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK932860 Date28 Sep 1993DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10381780025788 registered 24 Sep 2026 Active
  • FDA 510(k) K932860 decided 28 Sep 1993 Active
  • FDA GUDID UDI-DI 10381780025788 listed 26 Jul 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K932860
  2. Listed FDA GUDID 10381780025788
  3. Registered EUDAMED B-10381780025788

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  • Withdrawn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 (Adults)
Model / Ref / Catalog
A1083
Primary DI / UDI-DI
10381780025788
Basic UDI-DI
B-10381780025788
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
Ethylene Oxide
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 10381780025788: EUDAMED states No, FDA GUDID states Yes.

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 (K932860)

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

  • Supplied sterile
  • Sterilise before use NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)