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PerFuse™ Decompression System 800-0543

by Biomet Orthopedics, Inc.

Ref 800-0543

PerFuse™ Decompression System 800-0543 is a device classified as Class I in the EU and Class II in the US made by Biomet Orthopedics, Inc., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI 889024ADDZ3), cleared under FDA 510(k) K141762 on 27 Aug 2014 and listed in FDA GUDID since 18 Apr 2019 (UDI-DI 00887868263040), active as of 7 Nov 2026. One FDA recall is linked to it.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K141762

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number889024ADDZ3 Basic UDI-DI 00887868263040UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00887868263040 UDI-DI Date18 Apr 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK141762 Date27 Aug 2014DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024ADDZ3 registered 6 Nov 2026 Active
  • FDA 510(k) K141762 decided 27 Aug 2014 Active
  • FDA GUDID UDI-DI 00887868263040 listed 18 Apr 2019 Listed

Recalls

1 recall · FDA

    • Terminated Z-1814-2016 FDA Class II initiated 11 Apr 2016

    The Trocar and Plunger Assemblies are missing from the instrument, which could result in a delay in surgery greater than 30 minutes.

Timeline

4 dated events

  1. Cleared FDA 510(k) K141762
  2. Recall initiated FDA recalls Z-1814-2016
  3. Listed FDA GUDID 00887868263040
  4. Registered EUDAMED 889024ADDZ3

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
PerFuse™ Decompression System
Generic name
Surgical instrument handle, non-torque-limiting
Device name
Biomet Slide Hammer Adapter
Model / Ref / Catalog
800-0543
Primary DI / UDI-DI
00887868263040
Basic UDI-DI
889024ADDZ3
Direct marketing DI
00887868263040
510(k) Number
FDA product code
FMF
EMDN code
B06 Cellular or biological manipulation devices
GMDN term
Surgical instrument handle, non-torque-limiting
Device class
Class I EUDAMED
Class II GUDID
Regulation number
880.5860
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Surgical instrument handle, non-torque-limiting

Cleared under the same submission (K141762)

and 8 more cleared under K141762

Similar devices in this category

Other devices filed under CELLULAR OR BIOLOGICAL MANIPULATION DEVICES.

Other devices from Biomet Orthopedics, Inc.

See all devices from Biomet Orthopedics, Inc. →

Properties

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