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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
Bone screw fixation sleeve FDA UDI
Device Name
Universal Window Joint Seeker FDA UDI
Model / Reference
TN-MF-7052 FDA UDI
Description
Universal Window Joint Seeker FDA UDI

Identifiers

Catalog Number
TN-MF-7052 FDA UDI
Primary DI / UDI-DI
00840124520011 FDA UDI
510(k) Number
K211843 FDA UDI
FDA Product Code
QAC FDA UDI
GMDN Term
Bone screw fixation sleeve FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3043 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

Yes

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: Bone screw fixation sleeve

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

Similar devices

Also classified as Bone screw fixation sleeve.

Cleared under the same submission

K211843 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 c0098e34-d40c-478a-8ffa-0efb6a2f17f1 35 fields · synced May 30, 2026