Identity
- Trade Name
- Integrated Spine System FDA UDI
- Generic Name
- Spinal bone set screw FDA UDI
- Device Name
- Cap and Set Screw FDA UDI
- Model / Reference
- 158-5000-01 FDA UDI
- Description
- Cap and Set Screw FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822409030675 FDA UDI
- 510(k) Number
- K061524 FDA UDI
- FDA Product Code
- MNH FDA UDIMNI FDA UDIKWP FDA UDI
- GMDN Term
- Spinal bone set screw 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
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Integrated Spine System by Ortho Development Corp. — 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
- Ortho Development Corp.
Sources (1)
- FDA UDI 8e0c4913-ca53-4d22-838b-2b8fa6745aa0 36 fields · synced Jun 6, 2026