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Crescent Spinal System

by Medtronic Sofamor Danek, Inc.

510(k) K094025

Crescent Spinal System is a Class II device made by Medtronic Sofamor Danek, Inc., cleared under FDA 510(k) K172199 on 19 Sep 2017 (1 earlier submission) and listed in FDA GUDID since 18 Aug 2015 (UDI-DI 00613994187772), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

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

Source FDA 510(k), GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK172199 Date19 Sep 2017DecidedStatusActive
United StatesGUDID listing GUDID Number00613994187772 UDI-DI Date18 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK094025 Date26 Apr 2010ClearedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K172199 decided 19 Sep 2017 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00613994187772 listed 18 Aug 2015 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K094025
  2. Listed FDA GUDID 00613994187772
  3. Cleared FDA 510(k) K172199

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  • Withdrawn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
Metallic spinal interbody fusion cage
Model / reference
9393612
FDA applicant
Medtronic Sofamor Danek
Primary DI / UDI-DI
00613994187772
510(k) Number
FDA product code
MAX
GMDN term
Metallic spinal interbody fusion cage
Device class
Class II
Regulation
21 CFR Part 888.3080
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent
GUDID distribution status
In Commercial Distribution

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

10 more clearances cite this device.

Source: 510k-lineage (choiben314), CC BY 4.0

Other devices from Medtronic Sofamor Danek, Inc.

See all devices from Medtronic Sofamor Danek, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
Other properties (10, all answered No)