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710.151.97S

by Synthes GmbH

710.151.97S (71015197S) is a Class II device made by Synthes GmbH, cleared under FDA 510(k) K051720 on 25 Jul 2005 and listed in FDA GUDID since 30 Jun 2016 (UDI-DI 10886982255808), active as of 12 Nov 2026. One FDA recall is linked to it.

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

1 closed

Documents

510(k) K051720

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10886982255808 UDI-DI Date30 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK051720 Date25 Jul 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K051720 decided 25 Jul 2005 Active
  • FDA GUDID UDI-DI 10886982255808 listed 30 Jun 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-3273-2011 FDA Unclassified (pre-2012) initiated 26 Jan 2011

    Firm became aware that some systems were released to stock without going through the sterilization process.

Timeline

3 dated events

  1. Cleared FDA 510(k) K051720
  2. Recall initiated FDA recalls Z-3273-2011
  3. Listed FDA GUDID 10886982255808

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Bone graft delivery kit
Model / Ref / Catalog
710.151.97S, 71015197S
Primary DI / UDI-DI
10886982255808
510(k) Number
FDA product code
FMF
GMDN term
Bone graft delivery kit
Device class
Class II
Regulation number
880.5860
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bone graft delivery kit

Cleared under the same submission (K051720)

and 1 more cleared under K051720

Similar devices

Other devices filed under FDA product code FMF (Syringe, piston).

Other devices from Synthes GmbH

  • Tomofix

    Class IIb

  • 03.111.100S

    Class IIb

  • 68.134.011

    Class II

  • Volt 68.134.111

    Class II

See all devices from Synthes GmbH →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (9, all answered No)