Identity
- Trade Name
- PERFIX™ SPINAL SYSTEM FDA UDI
- Generic Name
- Bone awl, reusable FDA UDI
- Model / Reference
- SI0210 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800037585776 FDA UDI
- FDA Product Code
- HWJ FDA UDI
- GMDN Term
- Bone awl, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 888.4540 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
Yes
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: Bone awl, reusable
Perfix™ Spinal System by CG MedTech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Bone awl, reusable.
- Vital™ MIS Spinal Fixation System — BIOMET SPINE LLC · Class I
- Trigen — Smith & Nephew, Inc. · Class I
- Navigated Instruments — EVOLUTION SPINE, LLC · Class II
- PYRENEES Cervical Plate System — K2M, INC. · Class I
- Awl — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
- CONMED — Conmed Corporation · Class I
- Sklar® — Sklar Corporation · Class I
- Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
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 I | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- CG MedTech Co., Ltd.
Sources (1)
- FDA UDI 2c279b74-c99b-4274-8d6a-27c669f37514 32 fields · synced May 31, 2026