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Chs 71123194

by Smith & Nephew, Inc.

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 23 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK213126 Date29 Sep 2022DecidedStatusActive
United StatesGUDID listing Number03596010175113 UDI-DI Date25 Aug 2015ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Chs
Generic name
Orthopaedic bone screw (non-sliding)
Model / Ref / Catalog
71123194
Primary DI / UDI-DI
03596010175113
510(k) Number
FDA product code
KTT
GMDN term
Orthopaedic bone screw (non-sliding)
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Orthopaedic bone screw (non-sliding)

Cleared under the same submission (K210837)

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Cleared under the same submission (K213126)

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Cleared under the same submission (K993289)

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Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date

Other properties (9)

  • Sterilise before use: No
  • Contains latex: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Manufacturing date: No