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Kirschner wire K10 NS118

by IN2BONES

Kirschner wire K10 NS118 is a Class II device made by IN2BONES, cleared under FDA 510(k) K153204 on 1 Feb 2016 and listed in FDA GUDID since 18 Mar 2016 (UDI-DI 03760225715390), active as of 23 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 23 Oct 2026

Documents

510(k) K153204

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03760225715390 UDI-DI Date18 Mar 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK153204 Date1 Feb 2016IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153204 decided 1 Feb 2016 Active
  • FDA GUDID UDI-DI 03760225715390 listed 18 Mar 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153204
  2. Listed FDA GUDID 03760225715390

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Kirschner wire
Generic name
Orthopaedic bone pin, non-bioabsorbable
Model / Ref / Catalog
K10 NS118
Primary DI / UDI-DI
03760225715390
510(k) Number
FDA product code
HTY, FZX, JDW
GMDN term
Orthopaedic bone pin, non-bioabsorbable
Device class
Class II
Regulation number
888.3040, 878.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 1.8 Millimeter
Length — 150 Millimeter

Related devices

Category: Orthopaedic bone pin, non-bioabsorbable

Cleared under the same submission (K153204)

and 8 more cleared under K153204

Similar devices in this category

Other devices filed under Orthopaedic bone pin, non-bioabsorbable.

Other devices from IN2BONES

See all devices from IN2BONES →

Properties

  • Sterilise before use
  • Single use
  • Implantable
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)