Lapiplasty System 3R

FDA UDI

Class II (US FDA UDI)

by Treace Medical Concepts, Inc.

Identity

Trade Name: Lapiplasty System 3R FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: Anatomic Biplanar Implants FDA UDI
Model / Reference: SK23 FDA UDI
Description: Anatomic Biplanar Implants FDA UDI

Identifiers

Primary DI / UDI-DI: 00853114006167 FDA UDI
FDA Product Code: HRS FDA UDI
HWC FDA UDI
GMDN Term: Orthopaedic bone screw (non-sliding) FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3030 FDA UDI
888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Orthopaedic bone screw (non-sliding)Orthopaedic fixation plate, non-bioabsorbable

Lapiplasty System 3R by Treace Medical Concepts, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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 II	Pending data

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Manufacturer

Manufacturer: Treace Medical Concepts, Inc.

Sources (1)

FDA UDI 3dfbff14-832f-43eb-9657-2570f98e5ba3 33 fields · synced May 31, 2026