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Guide, 10mm CI-GUIDE-10

by Elevation Spine

Guide, 10mm CI-GUIDE-10 is a Class II device made by Elevation Spine, cleared under FDA 510(k) K190885 on 7 Aug 2019 and listed in FDA GUDID since 31 Dec 2019 (UDI-DI 00810017912445), 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

510(k) K190885

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00810017912445 UDI-DI Date31 Dec 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK190885 Date7 Aug 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190885 decided 7 Aug 2019 Active
  • FDA GUDID UDI-DI 00810017912445 listed 31 Dec 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K190885
  2. Listed FDA GUDID 00810017912445

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Guide, 10mm
Generic name
Internal spinal fixation procedure kit, single-use
Model / Ref / Catalog
CI-GUIDE-10
Primary DI / UDI-DI
00810017912445
510(k) Number
FDA product code
ODP, OVE, KWQ
GMDN term
Internal spinal fixation procedure kit, single-use
Device class
Class II
Regulation number
888.3080, 888.3060
GUDID distribution status
In Commercial Distribution

Related devices

Category: Internal spinal fixation procedure kit, single-use

Cleared under the same submission (K190885)

and 8 more cleared under K190885

Similar devices

Other devices filed under FDA product code ODP (Intervertebral Fusion Device With Bone Graft, Cervical).

Other devices from Elevation Spine

See all devices from Elevation Spine →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)