Stratis 2510SS
by Covidien LP
Stratis 2510SS is a Class II device made by Covidien LP, cleared under FDA 510(k) K041749 on 8 Sep 2004 and listed in FDA GUDID since 22 Oct 2015 (UDI-DI 10884521513716), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number10884521513716 | Date22 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK041749 | Date8 Sep 2004 | StatusActive |
Official records
- AccessGUDID record 10884521513716
- FDA 510(k) database K041749
Across registries
- FDA 510(k) K041749 decided 8 Sep 2004 Active
- FDA GUDID UDI-DI 10884521513716 listed 22 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K041749
- Listed FDA GUDID 10884521513716
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Stratis
- Generic name
- Knee arthroplasty force sensor balance kit
- Model / reference
- 2510SS
- Primary DI / UDI-DI
- 10884521513716
- 510(k) Number
- FDA product code
- HWC
- GMDN term
- Knee arthroplasty force sensor balance kit
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
- Size
- Width — 8 MillimeterLength — 25 Millimeter
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