Cortoss Bone Augmentation Material

510(k) K080108

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

4 closed

Documents

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK080108	Date5 Jun 2009Cleared	StatusActive

4 recalls · FDA

2 recalls, same reason
- Terminated Z-2101-2021 FDA Class II initiated 18 May 2021
- Terminated Z-2100-2021 FDA Class II initiated 18 May 2021
The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution.
- Terminated Z-1900-2020 FDA Class II initiated 1 Apr 2020
Shipments were transported outside of the required refrigerated temperature conditions. Potential hazards if used include nerve damage resulting in paralysis and increased potential for embolism.
- Terminated Z-3188-2011 FDA Unclassified (pre-2012) initiated 31 Mar 2011 on shared 510(k) K080108
Recalling firm has discovered through internal testing that the Cortoss(TM) Delivery Gun may abrade its packaging material under certain transportation and handling conditions. This abrasion may cause small holes or tears in the packaging material, which may not be immediately visible to the user. Although t the Cortoss(TM) Delivery Gun is provided in double pouches and there have been no report

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

1 jurisdiction

United States — FDA 510(k) Active

510(k)