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D-Rad Smart Pack 71158017

by Smith & Nephew, Inc.

D-Rad Smart Pack 71158017 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K132296 on 7 Jan 2014 and listed in FDA GUDID since 25 Aug 2015 (UDI-DI 00885556364345), 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 ongoing

4 closed

Documents

510(k) K132296

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 Number00885556364345 UDI-DI Date25 Aug 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK132296 Date7 Jan 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132296 decided 7 Jan 2014 Active
  • FDA GUDID UDI-DI 00885556364345 listed 25 Aug 2015 Listed

Recalls

4 recalls · FDA

    • Terminated Z-1317-2018 FDA Class II initiated 7 Mar 2018 on shared 510(k) K132296

    One lot of D-RAD Self-Taping Locking Screws used with the Distal Radius Fracture Kit were machined out of specification. Screws measured over tolerance within the head thread form by 0.002-0.003 inch.

  • 3 recalls, same reason

    • Terminated Z-1855-2017 FDA Class II initiated 9 Mar 2017 on shared 510(k) K132296
    • Terminated Z-1857-2017 FDA Class II initiated 9 Mar 2017 on shared 510(k) K132296
    • Terminated Z-1856-2017 FDA Class II initiated 9 Mar 2017 on shared 510(k) K132296

    The expiration dates on the labeling are incorrect, the actual expiration dates are before the date on the labeling.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

6 dated events

  1. Cleared FDA 510(k) K132296
  2. Listed FDA GUDID 00885556364345
  3. Recall initiated FDA recalls Z-1855-2017
  4. Recall initiated FDA recalls Z-1857-2017
  5. Recall initiated FDA recalls Z-1856-2017
  6. Recall initiated FDA recalls Z-1317-2018

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
D-Rad Smart Pack
Generic name
Surgical implant template, single-use
Model / Ref / Catalog
71158017
Primary DI / UDI-DI
00885556364345
510(k) Number
FDA product code
HRS
GMDN term
Surgical implant template, single-use
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical implant template, single-use

Cleared under the same submission (K132296)

and 8 more cleared under K132296

Similar devices in this category

Other devices filed under Surgical implant template, single-use.

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

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