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Sp-1533

by Biomet Microfixation, Inc

Ref SP-1533

Sp-1533 is a device classified as Class IIb in the EU and Class II in the US made by Biomet Microfixation, Inc, registered in EUDAMED on 23 Oct 2026 (Basic UDI-DI B-00841036088569), cleared under FDA 510(k) K121624 on 12 Oct 2012 (2 earlier submissions) and listed in FDA GUDID since 11 Oct 2015 (UDI-DI 00841036088569), active as of 7 Nov 2026. 6 FDA recalls are linked to it.

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 ongoing

11 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K121624

+2 more

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841036088569 Basic UDI-DI 00841036088569UDI-DIDate23 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841036088569 UDI-DI Date11 Oct 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK121624 Date12 Oct 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00841036088569 registered 23 Oct 2026 Active
  • FDA 510(k) K121624 decided 12 Oct 2012 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00841036088569 listed 11 Oct 2015 Listed

Recalls

11 recalls · FDA

    • Terminated Z-1220-2017 FDA Class II initiated 10 Jan 2017 on shared 510(k) K121589

    The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.

  • 2 recalls, same reason

    • Terminated Z-0137-2016 FDA Class II initiated 6 Aug 2015
    • Terminated Z-0136-2016 FDA Class II initiated 6 Aug 2015

    The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force.

  • 2 recalls, same reason

    • Terminated Z-0836-2012 FDA Unclassified (pre-2012) initiated 8 Nov 2010 on shared 510(k) K953385
    • Terminated Z-0835-2012 FDA Unclassified (pre-2012) initiated 8 Nov 2010 on shared 510(k) K953385

    On 11/08/2010 Biomet Microfixation, Jacksonville, FL initiated a recall of the Biomet 1 count (REF 91-1504, Lot 622120) and 5 count (REF 95-1504, Lot 622120) packages of 1.5MM System High Torque (HT) Cross-Drive Screw 5/Pk and the Biomet 1 count (REF 99-7204, Lot 202450) and 5 count packages (REF 01/7204, Lot 202450) of the 1.5MM System Center-Drive Screw, 5/Pk because of a possibility that thes

    • Terminated Z-2385-2011 FDA Unclassified (pre-2012) initiated 28 Jul 2010

    Biomet Microfixation, Jacksonville, FL is recalling their 1.5 6 Hole Reg Double Y, Lots 785710, 753120, 693500 and 733600. This product is labeled as 01-7110-K (1.5 6 Hole Reg Double Y), however the package contains a 01-7112-K (1.5.6 Hold Long Double Y).

    • Terminated Z-2873-2011 FDA Unclassified (pre-2012) initiated 17 May 2010 on shared 510(k) K953385

    On May 17, 2010, Biomet Microfixation issued a Safety Alert on their Thinflap System Cross Drive, Self Drilling Screw, 1.5x4mm, Model #: 91-6704, Lot#: 173770. The product is labeled incorrectly. Some packages of 91-6704 lot 173770 are labeled as cross drive screws, but contain center drive screws. All affected customers were notified of the recall on May 17, 2010.

    • Terminated Z-1286-2012 FDA Unclassified (pre-2012) initiated 26 Apr 2010

    On 4/26/10 Biomet Microfixation, Jacksonville, FL initiated a recall of their 1.5 3/3 hole 100 degree left X-long L plate, Model #01-7036, Lot #193690. Product is labeled incorrectly.

    • Terminated Z-2206-2010 FDA Unclassified (pre-2012) initiated 17 Mar 2010 on shared 510(k) K953385

    Biomet Microfixation has received a complaint from a customer who reports finding a 3.5mm length screw in one 5 pack of 4mm length screws.

    • Terminated Z-1151-2010 FDA Unclassified (pre-2012) initiated 6 Oct 2009

    Biomet Microfixation is recalling Model 01-7293 an Model 99-7293-01, 1.5X3.5mm Self Drilling, Low Profile, Cross Drive screw, 5/PK was found to contain a 91-6104 (1.5X4mm High Torque, Self Drilling, Cross Drive screw.

    • Terminated Z-1943-2010 FDA Unclassified (pre-2012) initiated 5 Oct 2009

    Biomet Microfixation is recalling 91-6103 1.5x3.5mm HT SD X-drive screw Lot Number 829760. This package may contain 91-6704 1.5x4mm ThinFlap SD X-drive screw.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

16 dated events

  1. Recall initiated FDA recalls Z-2385-2011
  2. Recall initiated FDA recalls Z-0836-2012
  3. Recall initiated FDA recalls Z-0835-2012
  4. Cleared FDA 510(k) K121589
  5. Cleared FDA 510(k) K121624
  6. Recall initiated FDA recalls Z-0137-2016
  7. Recall initiated FDA recalls Z-0136-2016
  8. Listed FDA GUDID 00841036088569
  9. Recall initiated FDA recalls Z-1220-2017
  10. Registered EUDAMED B-00841036088569

6 earlier events are in the sections above.

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

Generic name
Cranioplasty sheet
Device name
1.5/0.6mm Contour Mesh Panel
Model / Ref / Catalog
SP-1533
Primary DI / UDI-DI
00841036088569
Basic UDI-DI
B-00841036088569
510(k) Number
FDA product code
GWO, JEY, GXR, HBW
EMDN code
P09120503 Osteosynthesis screw-plate systems
GMDN term
Cranioplasty sheet
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
882.5320, 872.4760, 882.5250, 882.5360
EU registration type
Legacy device (under a directive)
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 IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Cranioplasty sheet

Cleared under the same submission (K121589)

and 8 more cleared under K121589

Cleared under the same submission (K121624)

and 8 more cleared under K121624

Similar devices

Also classified as Cranioplasty sheet.

Similar devices in this category

Other devices filed under OSTEOSYNTHESIS SCREW-PLATE SYSTEMS.

Other devices from Biomet Microfixation, Inc

See all devices from Biomet Microfixation, Inc →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)