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Ingenix 55016540

by Ingenium Spine

Ingenix 55016540 is a Class II device made by Ingenium Spine, cleared under FDA 510(k) K173126 on 5 Dec 2017 and listed in FDA GUDID since 15 Jun 2018 (UDI-DI 00843672100209), 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) K173126

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 Number00843672100209 UDI-DI Date15 Jun 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK173126 Date5 Dec 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K173126 decided 5 Dec 2017 Active
  • FDA GUDID UDI-DI 00843672100209 listed 15 Jun 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K173126
  2. Listed FDA GUDID 00843672100209

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ingenix
Generic name
Spinal bone screw, non-bioabsorbable
Model / reference
55016540
Primary DI / UDI-DI
00843672100209
510(k) Number
FDA product code
KWP, NKB
GMDN term
Spinal bone screw, non-bioabsorbable
Device class
Class II
Regulation number
888.3050, 888.3070
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K173126)

and 8 more cleared under K173126

Similar devices in this category

Other devices filed under Spinal bone screw, non-bioabsorbable.

Other devices from Ingenium Spine

See all devices from Ingenium Spine →

Properties

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