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Endoskeleton™ Interbody Systems

by Medtronic Sofamor Danek USA, Inc.

510(k) K251444Ref 22-05454-00

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

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) K251444↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0763000B000075284 Basic UDI-DI 00191375050674UDI-DIDate25 Aug 2026RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK251444 Date4 Sep 2025ClearedStatusActive
United StatesGUDID listing GUDID Number00191375050674 UDI-DI Date1 Nov 2019ListedStatusListed 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 25 Oct 2026.

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  • Withdrawn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 · 510(k) · GUDID

Trade Name
Endoskeleton™ EUDAMED
Endoskeleton® Tas GUDID
Generic Name
Instrument tray, reusable
Device Name
Medtronic Reusable Accessories - Titan
Model / Reference
22-05454-00
Primary DI / UDI-DI
00191375050674
Basic UDI-DI
0763000B000075284
510(k) Number
FDA Product Code
MAX 510(k)
LRP GUDID
EMDN Code
V0402 Clinical use trays and bowls
GMDN Term
Instrument tray, reusable
Device Class
Class I EUDAMEDGUDID
Class II 510(k)
Regulation
21 CFR Part 888.3080 510(k)
878.4800 GUDID
EU market of registration
Netherlands
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Width — 2 Inch
Length — 5 Inch

Truth per registry

3 sources · 3 fields differ

FieldEUDAMED510(k)GUDID
FDA Product CodeEUDAMED
—
510(k)
MAX
GUDID
LRP
Device ClassEUDAMED
Class I
510(k)
Class II
GUDID
Class I
Regulation NumberEUDAMED
—
510(k)
888.3080
GUDID
878.4800

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Properties

  • Reusable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (20)

  • 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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No