Identity
- Trade Name
- Kalitec Direct InSePtion MIS Fixation System FDA UDI
- Generic Name
- Interspinous spinal fixation implant FDA UDI
- Device Name
- Locking Plate, 10mm FDA UDI
- Model / Reference
- 14-ILP-0010 FDA UDI
- Description
- Locking Plate, 10mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- B07314ILP0010 FDA UDI
- FDA Product Code
- PEK FDA UDI
- GMDN Term
- Interspinous spinal fixation implant FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Kalitec Direct InSePtion MIS Fixation System by Kalitec Direct LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
- Kalitec Direct LLC
Sources (1)
- FDA UDI d0fa9de0-1b5c-4bd9-b817-534389f3fc79 34 fields · synced Jun 8, 2026