Identity
- Trade Name
- PolyLock FDA UDI
- Generic Name
- Surgical screwdriver, single-use FDA UDI
- Device Name
- MiniLock Cannulated Driver (3.5mm) FDA UDI
- Model / Reference
- CD-ML-3520 FDA UDI
- Description
- MiniLock Cannulated Driver (3.5mm) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840124510210 FDA UDI
- 510(k) Number
- K211843 FDA UDI
- FDA Product Code
- HWR FDA UDI
- GMDN Term
- Surgical screwdriver, single-use 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
Yes
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
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical screwdriver, single-use
PolyLock by Fusion Orthopedics, Llc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K211843 also covers:
- FuzeFix Chamfered Screws — FUSION ORTHOPEDICS, LLC
- LapiLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
- PolyLock — FUSION ORTHOPEDICS, LLC
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
- Fusion Orthopedics, Llc
Sources (1)
- FDA UDI f6ac695e-7bdd-4e6e-b229-ed6dc1266733 34 fields · synced May 30, 2026