Identity
- Trade Name
- INNOVERSE Spinal System FDA UDI
- Generic Name
- Spinal bone screw, non-bioabsorbable FDA UDI
- Model / Reference
- NPA6530CRD FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800308493021 FDA UDI
- 510(k) Number
- K233960 FDA UDI
- FDA Product Code
- NKB FDA UDI
- GMDN Term
- Spinal bone screw, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3070 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Spinal bone screw, non-bioabsorbable
Introducing the INNOVERSE Spinal System, a cutting-edge, non-bioabsorbable spinal implant designed for internal spinal fixation. Developed in partnership with CG MedTech Co., Ltd., this device provides unparalleled stability and immobilization of spinal segments, making it an ideal solution for orthopedic treatment.
Similar devices
Also classified as Spinal bone screw, non-bioabsorbable.
- 4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
- LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
- AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
- Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
- EVEREST® Spinal System — K2M, INC. · Class II
Cleared under the same submission
K233960 also covers:
- INNOVERSE Spinal System — CG MedTech Co., Ltd.
- INNOVERSE Spinal System — CG MedTech Co., Ltd.
- INNOVERSE Spinal System — CG MedTech Co., Ltd.
- INNOVERSE Spinal System — CG MedTech Co., Ltd.
- INNOVERSE Spinal System — CG MedTech Co., Ltd.
- INNOVERSE Spinal System — CG MedTech Co., Ltd.
- INNOVERSE Spinal System — CG MedTech Co., Ltd.
- INNOVERSE Spinal System — CG MedTech Co., Ltd.
- INNOVERSE Spinal System — CG MedTech Co., Ltd.
- INNOVERSE Spinal System — CG MedTech Co., Ltd.
- INNOVERSE Spinal System — CG MedTech Co., Ltd.
- INNOVERSE Spinal System — CG MedTech 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CG MedTech Co., Ltd.
Sources (1)
- FDA UDI 3859a3a1-c948-46cd-983d-e2ae049ede66 33 fields · synced Jul 20, 2026