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Peri-Loc 71173416

by Smith & Nephew, Inc.

Peri-Loc 71173416 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K123055 on 25 Jan 2013 and listed in FDA GUDID since 25 Aug 2015 (UDI-DI 03596010538390), 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) K123055

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 Number03596010538390 UDI-DI Date25 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK123055 Date25 Jan 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K123055 decided 25 Jan 2013 Active
  • FDA GUDID UDI-DI 03596010538390 listed 25 Aug 2015 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K123055
  2. Listed FDA GUDID 03596010538390

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Peri-Loc
Generic name
Orthopaedic intraoperative positioning pin, single-use
Model / Ref / Catalog
71173416
Primary DI / UDI-DI
03596010538390
510(k) Number
FDA product code
HRS
GMDN term
Orthopaedic intraoperative positioning pin, single-use
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution

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Properties

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