Identity
- Trade Name
- KANEDA SR FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system, non-sterile FDA UDI
- Device Name
- KANEDA SR ANTERIOR SYSTEM OPEN SCREW 6.35 x 7.0 x 50mm FDA UDI
- Model / Reference
- 52113250 FDA UDI
- Description
- KANEDA SR ANTERIOR SYSTEM OPEN SCREW 6.35 x 7.0 x 50mm FDA UDI
Identifiers
- Catalog Number
- 52113250 FDA UDI
- Primary DI / UDI-DI
- 10705034013794 FDA UDI
- 510(k) Number
- K971248 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
Kaneda Sr by Depuy Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Cleared under the same submission
K971248 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 2a88dbff-16bb-42cd-8ab8-9c3370dc7080 37 fields · synced Jun 8, 2026