Identity
- Trade Name
- Dyna-EXTOR II EXTERNAL FIXATION SYSTEM FDA UDI
- Generic Name
- Surgical screwdriver, reusable FDA UDI
- Device Name
- Screw Driver FDA UDI
- Model / Reference
- 36730 FDA UDI
- Description
- Screw Driver FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809763503412 FDA UDI
- FDA Product Code
- HXX FDA UDI
- GMDN Term
- Surgical screwdriver, 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical screwdriver, reusable
Dyna-EXTOR II EXTERNAL FIXATION SYSTEM by Bk Meditech Co., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Surgical screwdriver, reusable.
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- USS — Synthes · Class I
- Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class I
- CosmoLock Pedicle Screw System — Kalitec Direct LLC · Class I
- KLOCKNER — SOADCO, S.L. · 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 |
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Manufacturer
- Manufacturer
- Bk Meditech Co., Ltd.
Sources (1)
- FDA UDI 7f8f9177-231f-4900-823b-c9775f09ad8f 33 fields · synced May 30, 2026