Identity
- Trade Name
- DENALI® MI Spinal System FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Cannulated Poly Screw Size Ø7.5x100 mm FDA UDI
- Model / Reference
- M101-075100-SG FDA UDI
- Description
- Cannulated Poly Screw Size Ø7.5x100 mm FDA UDI
Identifiers
- Catalog Number
- M101-075100-SG FDA UDI
- Primary DI / UDI-DI
- 10888857147089 FDA UDI
- FDA Product Code
- MNH FDA UDIKWQ FDA UDINKB FDA UDIOSH FDA UDIMNI FDA UDIKWP FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3060 FDA UDI888.3050 FDA UDI
- Commercial Distribution
- Not 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Outer Diameter — 7.5 Millimeter FDA UDILength — 100 Millimeter FDA UDI
DENALI® MI Spinal System by K2m, Inc. — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- K2m, Inc.
Sources (1)
- FDA UDI fa26d6d1-b9c2-4f59-b0a6-06eab03ff4e4 37 fields · synced May 31, 2026