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Pro-fix™ Precision Fixation System PFB8-5

by Osteogenics Biomedical, Inc.

Ref PFB8-5Model Screw Fixation System - Bone Fixation Screw

Pro-fix™ Precision Fixation System PFB8-5 is a device classified as Class IIb in the EU and Class II in the US made by Osteogenics Biomedical, Inc., registered in EUDAMED on 20 Aug 2026 (Basic UDI-DI B-D765PFB851), cleared under FDA 510(k) K093719 on 1 Mar 2010 and listed in FDA GUDID since 21 Jan 2021 (UDI-DI D765PFB851), active as of 25 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 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K093719

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-D765PFB851 Basic UDI-DI D765PFB851UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD765PFB851 UDI-DI Date21 Jan 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK093719 Date1 Mar 2010DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-D765PFB851 registered 20 Aug 2026 Active
  • FDA 510(k) K093719 decided 1 Mar 2010 Active
  • FDA GUDID UDI-DI D765PFB851 listed 21 Jan 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K093719
  2. Listed FDA GUDID D765PFB851
  3. Registered EUDAMED B-D765PFB851

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  • Withdrawn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
Pro-Fix Precision Fixation System EUDAMED
Pro-fix™ Precision Fixation System GUDID
Generic name
Craniofacial bone screw, non-bioabsorbable
Device name
Pro-Fix Self-Tapping Bone Fixation Screw
Model / reference
PFB8-5, Screw Fixation System - Bone Fixation Screw
Primary DI / UDI-DI
D765PFB851
Basic UDI-DI
B-D765PFB851
510(k) Number
FDA product code
DZL
EMDN code
Q010399 Surgical dental devices - other
GMDN term
Craniofacial bone screw, non-bioabsorbable
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
872.4880
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Conditional
Size
Length — 8.0 Millimeter

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: Craniofacial bone screw, non-bioabsorbable

Cleared under the same submission (K093719)

and 8 more cleared under K093719

Similar devices in this category

Other devices filed under SURGICAL DENTAL DEVICES - OTHER.

Other devices from Osteogenics Biomedical, Inc.

See all devices from Osteogenics Biomedical, Inc. →

Properties

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