In2Bones

FDA UDI

Class I (US FDA UDI)

by In2Bones, USA

Identity

Trade Name: In2Bones FDA UDI
Generic Name: Orthopaedic surgical distractor, external FDA UDI
Device Name: BONE REDUCTION FORCEPS,5",SERRATED CURVED POINT.,Non-Sterile FDA UDI
Model / Reference: P07 N0201 FDA UDI
Description: BONE REDUCTION FORCEPS,5",SERRATED CURVED POINT.,Non-Sterile FDA UDI

Identifiers

Catalog Number: P07 N0201 FDA UDI
Primary DI / UDI-DI: 00810021865980 FDA UDI
510(k) Number: K181113 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Orthopaedic surgical distractor, external FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Orthopaedic surgical distractor, external

In2Bones by In2Bones, USA — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic surgical distractor, external.

Life Instruments — Life Instrument Corporation · Class I
MSI — Modern Surgical Instruments LLC · Class I
De Mayo Ankle Distractor™ — INNOVATIVE MEDICAL PRODUCTS, INC. · Class I
MSI — Modern Surgical Instruments LLC · Class I
Compressor & Distractor — TREACE MEDICAL CONCEPTS, INC. · Class I
Arthrex® — Arthrex, Inc. · Class I
Arthrex® — Arthrex, Inc. · Class I
Innomed, Inc. — Innomed, Inc. · Class I

Cleared under the same submission

K181113 also covers:

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 I	Pending data

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Manufacturer

Manufacturer: In2Bones, USA

Sources (1)

FDA UDI a6cea460-8996-4ea9-b7a4-89d94ee82b85 36 fields · synced May 30, 2026