Identity
- Trade Name
- ISOLA FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- ISOLA SPINE SYSTEM ANGLED SLOTTED CONNECTOR 6.35mm, 45 DEGREES FDA UDI
- Model / Reference
- 500005030 FDA UDI
- Description
- ISOLA SPINE SYSTEM ANGLED SLOTTED CONNECTOR 6.35mm, 45 DEGREES FDA UDI
Identifiers
- Catalog Number
- 500005030 FDA UDI
- Primary DI / UDI-DI
- 10705034226750 FDA UDI
- 510(k) Number
- K022285 FDA UDI
- FDA Product Code
- MNH FDA UDIKWP FDA UDIMNI FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile 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
No
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
Isola by Depuy Spine, 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 |
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Manufacturer
- Manufacturer
- Depuy Spine, Inc.
Sources (1)
- FDA UDI 30aa4b3b-75b1-4ec8-8c07-030ddd3d9ad6 37 fields · synced Jun 8, 2026