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Djo Surgical 344-11-707

by Encore Medical LP

Djo Surgical 344-11-707 is a Class II device made by Encore Medical LP, cleared under FDA 510(k) K170573 on 31 May 2017 and listed in FDA GUDID since 1 Jun 2017 (UDI-DI 00190446215240), active as of 8 Nov 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 8 Nov 2026

Documents

510(k) K170573

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00190446215240 UDI-DI Date1 Jun 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK170573 Date31 May 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K170573 decided 31 May 2017 Active
  • FDA GUDID UDI-DI 00190446215240 listed 1 Jun 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K170573
  2. Listed FDA GUDID 00190446215240

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Djo Surgical
Generic name
Tibial insert
Model / reference
344-11-707
Primary DI / UDI-DI
00190446215240
510(k) Number
FDA product code
OIY, JWH
GMDN term
Tibial insert
Device class
Class II
Regulation number
888.3560
GUDID distribution status
In Commercial Distribution

Related devices

Category: Tibial insert

Cleared under the same submission (K170573)

and 8 more cleared under K170573

Other devices from Encore Medical LP

See all devices from Encore Medical LP →

Properties

  • Supplied sterile
  • Implantable
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)