IMPlate Set Screw, 3.0mm x 2.0mm, CoCr
IMPlate Set Screw, 3.0mm x 2.0mm, CoCr (STSC-30020-CS) is a Class II device made by Skeletal Dynamics L.L.C., cleared under FDA 510(k) K092720 on 29 Jun 2010 and listed in FDA GUDID since 30 Oct 2015 (UDI-DI 00841506103105), active as of 22 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 | Number00841506103105 | Date30 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092720 | Date29 Jun 2010 | StatusActive |
Official records
- AccessGUDID record 00841506103105
- FDA 510(k) database K092720
Across registries
- FDA 510(k) K092720 decided 29 Jun 2010 Active
- FDA GUDID UDI-DI 00841506103105 listed 30 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K092720
- Listed FDA GUDID 00841506103105
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- IMPlate
- Generic name
- Implantable orthopaedic/craniofacial device connection screw
- Model / Ref / Catalog
- Set Screw, 3.0mm x 2.0mm, CoCr, STSC-30020-CS
- Primary DI / UDI-DI
- 00841506103105
- 510(k) Number
- FDA product code
- HSB
- GMDN term
- Implantable orthopaedic/craniofacial device connection screw
- Device class
- Class II
- Regulation number
- 888.3020
- GUDID distribution status
- In Commercial Distribution
- Size
- Outer Diameter — 2 Millimeter
Similar devices in this category
Other devices filed under Implantable orthopaedic/craniofacial device connection screw.
- LINK Endo-Model EVO 15-6118/30 by WALDEMAR LINK GmbH & Co. KG
- Link OptiStem 17-1001/00 by WALDEMAR LINK GmbH & Co. KG
- Hex Button 400-782 2232-02-25 by Pioneer Surgical Technology Inc.
- Pantheon PFR System Compression Screw 0200760 by ADLER ORTHO SPA
- Hex Button 400-776 2232-01-25 by Pioneer Surgical Technology Inc.
- Pantheon PFR System Compression Screw 0200740 by ADLER ORTHO SPA