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Cd Horizon Spinal System

by Medtronic Sofamor Danek, Inc. 2 variants

510(k) K011508

Active United States. Also listed in GUDID (US), not in commercial distribution.

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00721902287565 UDI-DI Date15 Jun 2015ListedStatusListed GUDID: not in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK011508 Date12 Jun 2001ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k) · GUDID

Generic Name
Bone-screw internal spinal fixation system, non-sterile
Model / Reference
8692152
Primary DI / UDI-DI
00721902287565
510(k) Number
FDA Product Code
KWP, MNH, KWQ, MNI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile
Device Class
Class II
Regulation
21 CFR Part 888.3050 510(k)GUDID
888.3070 GUDID
888.3060 GUDID
Advisory Committee
Orthopedic
FDA Decision
SESE Substantially Equivalent
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Other devices from Medtronic Sofamor Danek, Inc.

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Properties

  • Single Use
  • Prescription Use
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: 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