Identity
- Trade Name
- ENDOSKELETON® TCS FDA UDI
- Generic Name
- Bone awl, reusable FDA UDI
- Device Name
- 15 Deg Bayonetted Awl Guide, 2.0mm FDA UDI
- Model / Reference
- 5210-1073 FDA UDI
- Description
- 15 Deg Bayonetted Awl Guide, 2.0mm FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00191375030775 FDA UDI
- 510(k) Number
- K191565 FDA UDI
- FDA Product Code
- ODP FDA UDIOVE FDA UDILXH FDA UDI
- GMDN Term
- Bone awl, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI888.4540 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
- Outer Diameter — 2 Millimeter FDA UDILength — 10 Inch FDA UDI
Category: Bone awl, reusable
Endoskeleton® Tcs by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Bone awl, reusable.
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Cleared under the same submission
K191565 also covers:
- ENDOSKELETON® TCS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS Sterile Barrier System — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS Sterile Barrier System — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS Sterile Barrier System — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS Sterile Barrier System — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TCS Sterile Barrier System — 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 II | Pending data |
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Manufacturer
- Manufacturer
- Medtronic Sofamor Danek, Inc.
Sources (1)
- FDA UDI e90ebf3b-8952-4b70-8d31-ff90e73c268d 36 fields · synced Jun 1, 2026