Identity
- Trade Name
- APEX-DL Spine System FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- APEX-DL Ti Cannulated Poly Reduction Screw 4.75 x 50mm, Self-Tapping FDA UDI
- Model / Reference
- DPR6-4750C-F FDA UDI
- Description
- APEX-DL Ti Cannulated Poly Reduction Screw 4.75 x 50mm, Self-Tapping FDA UDI
Identifiers
- Primary DI / UDI-DI
- M824DPR64750CF1 FDA UDI
- FDA Product Code
- MNH FDA UDIOSH FDA UDIKWP FDA UDINKB FDA UDIMNI FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI888.3050 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
APEX-DL Spine System by Spinecraft 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Spinecraft Llc
Sources (1)
- FDA UDI 39448f85-a5c5-4cea-8386-815e2ebc8782 35 fields · synced Jun 8, 2026