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EXOGEN Metatarsal Strap 71034660

by Bioventus LLC

EXOGEN Metatarsal Strap 71034660 is a personal device holder (FDA Class II; FDA product code LOF, Stimulator, Bone Growth, Non-Invasive) made by Bioventus LLC, approved under FDA PMA P900009 on 5 Oct 1994 and listed in FDA GUDID since 17 Dec 2021 (UDI-DI M937710346601), active as of 23 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None ongoing

3 closed

Documents

PMA P900009

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 NumberM937710346601 UDI-DI Date17 Dec 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPRL from GUDID NumberP900009 Date5 Oct 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA PMA P900009 decided 5 Oct 1994 Active
  • FDA GUDID UDI-DI M937710346601 listed 17 Dec 2021 Listed

Recalls

3 recalls · FDA

    • Terminated Z-0810-2021 FDA Class II initiated 17 Dec 2020

    Product may contain white particulates that are microbial in nature.

  • 2 recalls, same reason

    • Terminated Z-1695-2009 FDA Unclassified (pre-2012) initiated 5 Jun 2009 on shared PMA P900009
    • Terminated Z-1696-2009 FDA Unclassified (pre-2012) initiated 5 Jun 2009 on shared PMA P900009

    Problems with transducer may result in a reduced ultrasound output.

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

Timeline

5 dated events

  1. Approved FDA PMA P900009
  2. Recall initiated FDA recalls Z-1695-2009
  3. Recall initiated FDA recalls Z-1696-2009
  4. Recall initiated FDA recalls Z-0810-2021
  5. Listed FDA GUDID M937710346601

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

GUDID

Trade name
EXOGEN Metatarsal Strap
Generic name
Personal device holder, single-use
Model / reference
71034660
Primary DI / UDI-DI
M937710346601
PMA number
FDA product code
LOF
GMDN term
Personal device holder, single-use
Device class
Class II
Regulation number
890.5870
GUDID distribution status
In Commercial Distribution

Related devices

Category: Personal device holder, single-use

Cleared under the same submission (P900009)

Similar devices

Other devices filed under FDA product code LOF (Stimulator, Bone Growth, Non-Invasive).

Other devices from Bioventus LLC

See all devices from Bioventus LLC →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)