Identity
- Trade Name
- ISOLA FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- ANTERIOR ISOLA SPINE SYSTEM OPEN SCREW 6.35 x 5.5 x 40mm FDA UDI
- Model / Reference
- 50112440 FDA UDI
- Description
- ANTERIOR ISOLA SPINE SYSTEM OPEN SCREW 6.35 x 5.5 x 40mm FDA UDI
Identifiers
- Catalog Number
- 50112440 FDA UDI
- Primary DI / UDI-DI
- 10705034012568 FDA UDI
- 510(k) Number
- K943819 FDA UDI
- FDA Product Code
- KWQ FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3060 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
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 4d74eede-26b5-40f2-a516-a4b97344f2f2 37 fields · synced Jun 8, 2026