Identity
- Trade Name
- Integrated Spine System FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system rod FDA UDI
- Device Name
- Diameter 5.5 mm x 120 mmCurved Rod Ti FDA UDI
- Model / Reference
- 158-0120 FDA UDI
- Description
- Diameter 5.5 mm x 120 mmCurved Rod Ti FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822409024360 FDA UDI
- 510(k) Number
- K061524 FDA UDI
- FDA Product Code
- KWP FDA UDIMNI FDA UDIMNH FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system rod FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3050 FDA UDI888.3070 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
Dimensions & Sizes
- Size
- Outer Diameter — 5.5 Millimeter FDA UDILength — 120 Millimeter 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 e45d47a5-9482-4296-b35d-fe0e387ebac7 37 fields · synced May 31, 2026