Identity
- Trade Name
- Integrated Spine System FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Device Name
- Diameter 7.5 x 55 mm Pedicle Screw FDA UDI
- Model / Reference
- 158-7555-01 FDA UDI
- Description
- Diameter 7.5 x 55 mm Pedicle Screw FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00822409030927 FDA UDI
- 510(k) Number
- K061524 FDA UDI
- FDA Product Code
- MNI FDA UDIMNH 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 UDI888.3050 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
Dimensions & Sizes
- Size
- Outer Diameter — 7.5 Millimeter FDA UDILength — 55 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 afa111b7-11e5-4968-9bbf-fd78bed4176c 37 fields · synced Jun 1, 2026