Identity
- Trade Name
- Perfix™ MIS FDA UDI
- Generic Name
- Bone-screw internal spinal fixation system connector FDA UDI
- Model / Reference
- SS6090 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800037566577 FDA UDI
- 510(k) Number
- K091725 FDA UDI
- FDA Product Code
- MNH FDA UDI
- GMDN Term
- Bone-screw internal spinal fixation system connector 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Bone-screw internal spinal fixation system connector
Perfix™ MIS by CG MedTech Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone-screw internal spinal fixation system connector.
- Arsenal — ALPHATEC SPINE, INC. · Class II
- Zodiac — ALPHATEC SPINE, INC. · Class II
- SOCORE - Spinal Stabilization System — NovaSpine · Class IIb
- LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
- SOCORE - Spinal Stabilization System — NovaSpine · Class IIb
- APEX Spine System — SPINECRAFT LLC · Class II
- ReLine — Nuvasive, Inc. · Class II
- APEX Spine System — SPINECRAFT LLC · Class II
Cleared under the same submission
K091725 also covers:
- Perfix™ MIS — CG MedTech Co., Ltd.
- Perfix™ Spinal System — CG MedTech Co., Ltd.
- Perfix™ Spinal System — CG MedTech Co., Ltd.
- Perfix™ Spinal System — CG MedTech Co., Ltd.
- Perfix™ Spinal System — CG MedTech Co., Ltd.
- Perfix™ Spinal System — CG MedTech Co., Ltd.
- Perfix™ Spinal System — CG MedTech Co., Ltd.
- Perfix™ Spinal System — CG MedTech Co., Ltd.
- Perfix™ Spinal System — CG MedTech Co., Ltd.
- Perfix™ Spinal System — CG MedTech Co., Ltd.
- Perfix™ Spinal System — CG MedTech Co., Ltd.
- Perfix™ 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 |
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Manufacturer
- Manufacturer
- CG MedTech Co., Ltd.
Sources (1)
- FDA UDI 97010f11-550e-4348-9351-f116b1a1311d 33 fields · synced Jun 1, 2026