Elite SPK Kit A000115
by Ncs Lab SRL
Elite SPK Kit A000115 is a Class II device made by Ncs Lab SRL, cleared under FDA 510(k) K160500 on 20 Apr 2016 and listed in FDA GUDID since 23 Dec 2016 (UDI-DI 08051122040018), 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 | Number08051122040018 | Date23 Dec 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK160500 | Date20 Apr 2016 | StatusActive |
Official records
- AccessGUDID record 08051122040018
- FDA 510(k) database K160500
Across registries
- FDA 510(k) K160500 decided 20 Apr 2016 Active
- FDA GUDID UDI-DI 08051122040018 listed 23 Dec 2016 Listed
Timeline
- Cleared FDA 510(k) K160500
- Listed FDA GUDID 08051122040018
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Elite SPK Kit
- Generic name
- Tendon/ligament bone anchor, non-bioabsorbable
- Model / Ref / Catalog
- A000115
- Primary DI / UDI-DI
- 08051122040018
- 510(k) Number
- FDA product code
- MBI
- GMDN term
- Tendon/ligament bone anchor, non-bioabsorbable
- Device class
- Class II
- Regulation number
- 888.3040
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Tendon/ligament bone anchor, non-bioabsorbable.
- GFS II Standard, Large and Mini 10707 by PARCUS MEDICAL LLC
- Ti Screw ES 902572 by Biomet Orthopedics, Inc.
- CONMED C2854 by Conmed Corporation
- JuggerKnot® Soft Anchors 912075 by Biomet Orthopedics, Inc.
- Arthrex® AR-1324SF by Arthrex, Inc.
- GUARDSMAN 255020 by Conmed Corporation
- 10016 by Innovate Orthopaedics, Ltd.
- Titanium Interference Screw 10003 by PARCUS MEDICAL LLC
- Arthrex® AR-1665PPL by Arthrex, Inc.
- BT LOOP BTBXL01709 by S.B.M