Lapiplasty Mini Incision System

FDA UDI

Class II (US FDA UDI)

by Treace Medical Concepts, Inc.

Identity

Trade Name: Lapiplasty Mini Incision System FDA UDI
Generic Name: Orthopaedic bone screw (non-sliding) FDA UDI
Device Name: Anatomic Biplanar Implants FDA UDI
Model / Reference: SK30 FDA UDI
Description: Anatomic Biplanar Implants FDA UDI

Identifiers

Primary DI / UDI-DI: 00853114006211 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 Mini Incision System by Treace Medical Concepts, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic fixation plate, non-bioabsorbable.

Peri-Loc — Smith & Nephew, Inc. · Class II
Traufix osteosynthesis, osteotomy, and arthrodesis devices — Fixier S.A. DE C.V. · Class II
PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
AXSOS — Stryker Corp. · Class II
Xpert Wrist — NEWCLIP TECHNICS · Class II
ACUMED — ACUMED LLC · Class II
Anatomska ploča medial distal tibia 6 otvora D — Narcissus doo · Class IIb
ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Treace Medical Concepts, Inc.

Sources (1)

FDA UDI 91b985d7-2e6c-4f16-9de1-0e7ffd407f52 33 fields · synced May 31, 2026