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Rod

by Medtronic Sofamor Danek USA, Inc.

Ref G36537130

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 Number0763000B00032017F Basic UDI-DI 00199150015757UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00199150015757 UDI-DI Date29 Jun 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  • Withdrawn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
INFINITY™ Occipitocervical Upper Thoracic System
Generic Name
Bone-screw internal spinal fixation system rod
Device Name
Rod
Model / Reference
G36537130
Primary DI / UDI-DI
00199150015757
Basic UDI-DI
0763000B00032017F
510(k) Number
FDA Product Code
KWP, NKG
EMDN Code
P09070399 Implantable spinal stabilisation or fixation systems - other
GMDN Term
Bone-screw internal spinal fixation system rod
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3050, 888.3075
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000023095
Authorised representative
Medtronic B.V. NL-AR-000006050

Other devices from Medtronic Sofamor Danek USA, Incorporated

See all devices from Medtronic Sofamor Danek USA, Incorporated →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Sutures
  • Prescription Use
  • Lot / Batch Number

Other properties (19)

  • Reusable: 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