Stryker Injectable Cement
by Stryker
510(k) K060763
Stryker Injectable Cement is a Class II device made by Stryker, cleared under FDA 510(k) K060763 on 22 Sep 2006, active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
None ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060763 | Date22 Sep 2006 | StatusActive |
Official records
- FDA 510(k) database K060763
Recalls
-
- Terminated Z-2054-2013
Stryker received reports of the desiccant bag in the kit leaking silica gel granulate. This could increase exposure to anesthesia during surgical delay up to 60 minutes or inadvertent implantation of silica gel granulate which could cause foreign body reaction including inflammation and might lead to the need for revision surgery.
Timeline
- Cleared FDA 510(k) K060763
- Recall initiated FDA recalls Z-2054-2013
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- GXP
- Device class
- Class II
- Regulation
- 21 CFR Part 882.5300
- Advisory committee
- Neurology
- FDA decision
- SESE Substantially Equivalent
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