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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
Custom-made orthopaedic/craniofacial surgical guide FDA UDI
Device Name
Cutting Window Universal (Sterile) FDA UDI
Model / Reference
TN-MF-7050-S FDA UDI
Description
Cutting Window Universal (Sterile) FDA UDI

Identifiers

Catalog Number
TN-MF-7050-S FDA UDI
Primary DI / UDI-DI
00840124514751 FDA UDI
510(k) Number
K211843 FDA UDI
FDA Product Code
PBF FDA UDI
GMDN Term
Custom-made orthopaedic/craniofacial surgical guide FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3030 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

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

Category: Custom-made orthopaedic/craniofacial surgical guide

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

Similar devices

Also classified as Custom-made orthopaedic/craniofacial surgical guide.

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 f2cdf56a-f478-4377-bb08-d76af4cd3869 35 fields · synced Jun 8, 2026