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OsteoStrux Putty 56070100

by Isotis Orthobiologics, Inc

OsteoStrux Putty 56070100 is a Class II device made by Isotis Orthobiologics, Inc, cleared under FDA 510(k) K062353 on 20 Dec 2006 and listed in FDA GUDID since 24 Sep 2015 (UDI-DI 10889981055981), active as of 23 Oct 2026. 3 FDA recalls are 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

3 closed

Documents

510(k) K062353

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 Number10889981055981 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK062353 Date20 Dec 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K062353 decided 20 Dec 2006 Active
  • FDA GUDID UDI-DI 10889981055981 listed 24 Sep 2015 Listed

Recalls

3 recalls · FDA

    • Terminated Z-1796-2012 FDA Class II initiated 11 Oct 2011

    The Instructions for Use {HIFU} {Putty Part Number 7700713001 and Strip Part Number 770151300 l for CE marked Mozaik Strip and Putty products contains an incorrect translation of the term "bone marrow aspirate". The term is incorrectly translated in Spanish and French,

    • Terminated Z-0986-2012 FDA Unclassified (pre-2012) initiated 7 Oct 2011

    Integra OS Osteoconductive Putty is labeled with incorrect storage conditions.

    • Terminated Z-1034-2009 FDA Unclassified (pre-2012) initiated 16 Jan 2009

    Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained.

Timeline

5 dated events

  1. Cleared FDA 510(k) K062353
  2. Recall initiated FDA recalls Z-1034-2009
  3. Recall initiated FDA recalls Z-0986-2012
  4. Recall initiated FDA recalls Z-1796-2012
  5. Listed FDA GUDID 10889981055981

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
OsteoStrux Putty
Generic name
Orthopaedic bone void filling material, synthetic/animal-derived
Model / Ref / Catalog
56070100
Primary DI / UDI-DI
10889981055981
510(k) Number
FDA product code
MQV
GMDN term
Orthopaedic bone void filling material, synthetic/animal-derived
Device class
Class II
Regulation number
888.3045
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bone matrix implant, composite

Cleared under the same submission (K062353)

and 8 more cleared under K062353

Similar devices

Other devices filed under FDA product code MQV (FILLER, BONE VOID, CALCIUM COMPOUND).

Other devices from Isotis Orthobiologics, Inc

See all devices from Isotis Orthobiologics, Inc →

Properties

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