Identity
- Trade Name
- ISOLA FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- ISOLA SPINE SYSTEM TRANSVERSE ROD CONNECTOR 4.75mm FDA UDI
- Model / Reference
- 223008 FDA UDI
- Description
- ISOLA SPINE SYSTEM TRANSVERSE ROD CONNECTOR 4.75mm FDA UDI
Identifiers
- Catalog Number
- 223008 FDA UDI
- Primary DI / UDI-DI
- 10705034001814 FDA UDI
- 510(k) Number
- K980485 FDA UDI
- FDA Product Code
- MNH FDA UDIKWP FDA UDIKWQ 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 UDI888.3060 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
Cleared under the same submission
K980485 also covers:
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 5ff14b10-c1d1-4342-8468-fc5545d6671b 37 fields · synced May 31, 2026