Identity
- Trade Name
- Elite SPK Kit FDA UDI
- Generic Name
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
- Device Name
- The implantable device Elite SPK is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tears. The implant device is packaged with previously cleared sutures, in their final sterilized form FDA UDI
- Model / Reference
- A000115 FDA UDI
- Description
- The implantable device Elite SPK is intended for the attachment of soft tissue to bone during arthroscopic or open treatment of rotator cuff tears. The implant device is packaged with previously cleared sutures, in their final sterilized form FDA UDI
Identifiers
- Catalog Number
- A000115 FDA UDI
- Primary DI / UDI-DI
- 08051122040018 FDA UDI
- 510(k) Number
- K160500 FDA UDI
- FDA Product Code
- MBI FDA UDI
- GMDN Term
- Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Tendon/ligament bone anchor, non-bioabsorbable
Elite SPK Kit by Ncs Lab Srl — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Ncs Lab Srl
Sources (1)
- FDA UDI 631d6b86-e748-42d7-8344-df1df242f7ff 35 fields · synced May 30, 2026