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Synergy Disc Pilot Cutter

by Synergy Spine Solutions Inc. 3 variants

Ref 910-00010-96Model UDI50021 - Pilot Cutter

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++M670UDI50021X9 Basic UDI-DI +M67091000010960GUDI-DIDate12 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+M67091000010960G UDI-DI Date17 Apr 2026ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Synergy Disc Instruments
Generic Name
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Name
Synergy Disc Pilot Cutter
Model / Ref / Catalog
UDI50021 - Pilot Cutter, 910-00010-96
Primary DI / UDI-DI
+M67091000010960G EUDAMED
M67091000010960 GUDID
Basic UDI-DI
++M670UDI50021X9
510(k) Number
FDA Product Code
QLQ
EMDN Code
L090901 Bone cutters, reusable
GMDN Term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
888.4515
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Height — 6 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
+M67091000010960G
GUDID
M67091000010960
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000014165
Authorised representative
MedNet EC-REP III GmbH DE-AR-000011191

Other devices from Synergy Spine Solutions Inc.

See all devices from Synergy Spine Solutions Inc. →

Properties

  • Reusable
  • Prescription Use
  • Lot / Batch Number

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No