Identity
- Trade Name
- ENDOSKELETON® TA FDA UDI
- Generic Name
- Bone file/rasp, manual, reusable FDA UDI
- Device Name
- 7 Deg Lordotic, Rasp, Standard, 9mm FDA UDI
- Model / Reference
- 2106-7109 FDA UDI
- Description
- 7 Deg Lordotic, Rasp, Standard, 9mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00191375000464 FDA UDI
- 510(k) Number
- K080615 FDA UDI
- FDA Product Code
- LXH FDA UDIHTR FDA UDI
- GMDN Term
- Bone file/rasp, manual, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 FDA UDI878.4800 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
Dimensions & Sizes
- Size
- Depth — 21 Millimeter FDA UDIAngle — 7 degree FDA UDIWidth — 32 Millimeter FDA UDIHeight — 9 Millimeter FDA UDI
Category: Bone file/rasp, manual, reusable
Endoskeleton® Ta by Medtronic Sofamor Danek, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K080615 also covers:
- ENDOSKELETON® TA — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TA — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TA — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TA — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TA — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TA — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TA — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TA — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TA — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TA — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TA — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TA — MEDTRONIC SOFAMOR DANEK, INC.
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 I | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI b4bffce9-e182-4470-9c30-383a22025906 36 fields · synced May 30, 2026