IMPLATE Connector, 12mm x 0°
IMPLATE Connector, 12mm x 0° (IMP-WC-1200) 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 00841506102412), 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 | Number00841506102412 | Date30 Oct 2015 | StatusListed |
| United States | FDA 510(k)SESE | NumberK092720 | Date29 Jun 2010 | StatusActive |
Official records
- AccessGUDID record 00841506102412
- FDA 510(k) database K092720
Across registries
- FDA 510(k) K092720 decided 29 Jun 2010 Active
- FDA GUDID UDI-DI 00841506102412 listed 30 Oct 2015 Listed
Timeline
- Cleared FDA 510(k) K092720
- Listed FDA GUDID 00841506102412
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- Withdrawn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
- IMPLATE Connector, 12mm x 0°, IMP-WC-1200
- Primary DI / UDI-DI
- 00841506102412
- 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
- Length — 12 Millimeter
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