Identity
- Trade Name
- Endoskeleton™ TL Interbody System FDA UDI
- Generic Name
- Spinal fixation plate, non-bioabsorbable FDA UDI
- Device Name
- MODULAR 7300-0116-S TLH LAT 1 HOLE 16MM FDA UDI
- Model / Reference
- 7300-0116-S FDA UDI
- Description
- MODULAR 7300-0116-S TLH LAT 1 HOLE 16MM FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00191375031932 FDA UDI
- FDA Product Code
- OVD FDA UDI
- GMDN Term
- Spinal fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3080 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
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
Category: Spinal fixation plate, non-bioabsorbable
Endoskeleton™ TL Interbody System by Medtronic Sofamor Danek, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Spinal fixation plate, non-bioabsorbable.
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Cleared under the same submission
K191581 also covers:
- Endoskeleton™ TL Hyperlordotic Interbody System with Titan nanoLOCK™ Surface Tec — MEDTRONIC SOFAMOR DANEK, INC.
- Endoskeleton™ TL Interbody System — MEDTRONIC SOFAMOR DANEK, INC.
- Endoskeleton™ TL Interbody System — MEDTRONIC SOFAMOR DANEK, INC.
- Endoskeleton™ TL Interbody System — MEDTRONIC SOFAMOR DANEK, INC.
- Endoskeleton™ TL Interbody System — MEDTRONIC SOFAMOR DANEK, INC.
- Endoskeleton™ TL Interbody System — MEDTRONIC SOFAMOR DANEK, INC.
- Endoskeleton™ TL Interbody System with Titan nanoLOCK™ Surface Technology — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TL Hyperlordotic — Titan Spine, Inc.
- ENDOSKELETON® TL Hyperlordotic — Titan Spine, Inc.
- ENDOSKELETON® TL Hyperlordotic Sterile Barrier System — Titan Spine, Inc.
- ENDOSKELETON® TL Hyperlordotic Sterile Barrier System — Titan Spine, Inc.
- ENDOSKELETON® TL Hyperlordotic Sterile Barrier System — Titan Spine, Inc.
K192018 also covers:
- ENDOSKELETON® TA nanoLOCK® Surface Technology — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS Hyperlordotic nanoLOCK® Surface Technology — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS Sterile Barrier System — MEDTRONIC SOFAMOR DANEK, INC.
- ENDOSKELETON® TAS 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 b3a35232-1501-4b59-9a70-315410a826ae 35 fields · synced Jun 8, 2026