Identity
- Trade Name
- ASPIRON S ACP SYSTEM FDA UDI
- Generic Name
- Intraoperative bone pin/screw, non-sterile FDA UDI
- Model / Reference
- FC7330 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800037550866 FDA UDI
- FDA Product Code
- LXH FDA UDI
- GMDN Term
- Intraoperative bone pin/screw, non-sterile 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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Intraoperative bone pin/screw, non-sterile
Aspiron S Acp System by CG MedTech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Intraoperative bone pin/screw, non-sterile.
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC · Class II
- GPS — Exactech, Inc. · Class I
- Vantage — Exactech, Inc. · Class I
- Steinmann Pin Single Trocar Round 12" 2.4MM — BIOPRO, INC. · Class II
- Vantage — Exactech, Inc. · Class I
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC · Class II
- ADVANCE® — MicroPort Orthopedics Inc. · Class I
- Sacroiliac Joint Fusion System — Genesys Orthopedics Systems LLC · Class II
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 76918c0d-5c06-48d0-8c5e-bb6c8c58d2fd 32 fields · synced May 31, 2026