Identity
- Trade Name
- LOSPA IS Spinal System FDA UDI
- Generic Name
- Polymeric spinal fusion cage, sterile FDA UDI
- Device Name
- LOSPA IS TLIF Cage B Type (Sterile) FDA UDI
- Model / Reference
- SC.H60.3212 FDA UDI
- Description
- LOSPA IS TLIF Cage B Type (Sterile) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800017218175 FDA UDI
- 510(k) Number
- K170243 FDA UDI
- FDA Product Code
- MAX FDA UDI
- GMDN Term
- Polymeric spinal fusion cage, sterile 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Polymeric spinal fusion cage, sterile
LOSPA IS Spinal System by Corentec Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polymeric spinal fusion cage, sterile.
- TALOS® IBF — MEDITECH SPINE, LLC · Class II
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- TiNano — AURORA SPINE, INC. · Class II
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE · Class II
- Aurora Spine — AURORA SPINE, INC. · Class II
- TALOS®-C — MEDITECH SPINE, LLC · Class II
- Avenue T — Ldr Spine USA · Class II
- EVOS Lumbar Interbody System — CUTTING EDGE SPINE · Class II
Cleared under the same submission
K170243 also covers:
- LOSPA IS Spinal System — Corentec Co., Ltd
- LOSPA IS Spinal System — Corentec Co., Ltd
- LOSPA IS Spinal System — Corentec Co., Ltd
- LOSPA IS Spinal System — Corentec Co., Ltd
- LOSPA IS Spinal System — Corentec Co., Ltd
- LOSPA IS Spinal System — Corentec Co., Ltd
- LOSPA IS Spinal System — Corentec Co., Ltd
- LOSPA IS Spinal System — Corentec Co., Ltd
- LOSPA IS Spinal System — Corentec Co., Ltd
- LOSPA IS Spinal System — Corentec Co., Ltd
- LOSPA IS Spinal System — Corentec Co., Ltd
- LOSPA IS Spinal System — Corentec Co., Ltd
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
- Corentec Co., Ltd
Sources (1)
- FDA UDI f90a854f-5acd-4a29-acde-11896bba7e59 35 fields · synced May 31, 2026