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Pectus System 01-3815

by Biomet Microfixation, Inc

Part of a family of 22 devices: see the family page

Ref 01-3815

Pectus System 01-3815 is a device classified as Class I in the EU and Class II in the US made by Biomet Microfixation, Inc, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI 889024YZMF), cleared under FDA 510(k) K972420 on 11 Aug 1997 and listed in FDA GUDID since 15 Jun 2016 (UDI-DI 00841036011185), active as of 7 Nov 2026.

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 found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K972420

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 Number889024YZMF Basic UDI-DI 00841036011185UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841036011185 UDI-DI Date15 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK972420 Date11 Aug 1997DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 889024YZMF registered 23 Oct 2026 Active
  • FDA 510(k) K972420 decided 11 Aug 1997 Active
  • FDA GUDID UDI-DI 00841036011185 listed 15 Jun 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K972420
  2. Listed FDA GUDID 00841036011185
  3. Registered EUDAMED 889024YZMF

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  • Withdrawn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
Pectus System
Generic name
Surgical implant template, reusable
Device name
Pectus Instruments
Model / Ref / Catalog
01-3815
Primary DI / UDI-DI
00841036011185
Basic UDI-DI
889024YZMF
Direct marketing DI
00841036011185
510(k) Number
FDA product code
HRS
EMDN code
L091002 Instruments for processing materials for osteosynthesis, reusable
GMDN term
Surgical implant template, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
888.3030
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 implant template, reusable

Cleared under the same submission (K972420)

and 8 more cleared under K972420

Similar devices in this category

Other devices filed under INSTRUMENTS FOR PROCESSING MATERIALS FOR OSTEOSYNTHESIS, REUSABLE.

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (22, all answered No)