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PolyLock Midfoot

FDA UDI

Class II (US FDA UDI)

by Fusion Orthopedics, Llc

Identity

Trade Name
PolyLock Midfoot FDA UDI
Generic Name
Screw-extraction orthopaedic reamer, single-use FDA UDI
Device Name
Calibrated Drill MF Solid 3.5mm & 4.0mm FDA UDI
Model / Reference
CD-MF-1575 FDA UDI
Description
Calibrated Drill MF Solid 3.5mm & 4.0mm FDA UDI

Identifiers

Catalog Number
CD-MF-1575 FDA UDI
Primary DI / UDI-DI
00840124506527 FDA UDI
510(k) Number
K202959 FDA UDI
FDA Product Code
HWC FDA UDI
GMDN Term
Screw-extraction orthopaedic reamer, single-use FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3040 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
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Screw-extraction orthopaedic reamer, single-use

PolyLock Midfoot by Fusion Orthopedics, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Screw-extraction orthopaedic reamer, single-use.

Cleared under the same submission

K202959 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Fusion Orthopedics, Llc

Sources (1)

  • FDA UDI cab20886-8c05-45e7-a0c6-2e455e431e64 35 fields · synced Jun 8, 2026