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D-Rad Smart Pack 71158019

by Smith & Nephew, Inc.

D-Rad Smart Pack 71158019 is a Class II device made by Smith & Nephew, Inc., cleared under FDA 510(k) K213126 on 29 Sep 2022 (2 earlier submissions) and listed in FDA GUDID since 21 Sep 2015 (UDI-DI 00885556364444), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

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 Number00885556364444 UDI-DI Date21 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213126 decided 29 Sep 2022 Active· +2 more in the status table
  • FDA GUDID UDI-DI 00885556364444 listed 21 Sep 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

8 dated events

  1. Cleared FDA 510(k) K132296
  2. Listed FDA GUDID 00885556364444
  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
  7. Cleared FDA 510(k) K210837
  8. Cleared FDA 510(k) K213126

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  • Withdrawn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
Orthopaedic fixation plate, non-bioabsorbable
Model / Ref / Catalog
71158019
Primary DI / UDI-DI
00885556364444
510(k) Number
FDA product code
HRS
GMDN term
Orthopaedic fixation plate, non-bioabsorbable
Device class
Class II
Regulation number
888.3030
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Orthopaedic fixation plate, non-bioabsorbable

Cleared under the same submission (K132296)

and 8 more cleared under K132296

Cleared under the same submission (K210837)

and 8 more cleared under K210837

Similar devices in this category

Other devices filed under Orthopaedic fixation plate, non-bioabsorbable.

Other devices from Smith & Nephew, Inc.

See all devices from Smith & Nephew, Inc. →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (8, all answered No)