iNSitu™ Hip System

FDA UDI

Class I (US FDA UDI)

by Nextstep Arthropedix

Identity

Trade Name: iNSitu™ Hip System FDA UDI
Generic Name: Orthopaedic fixation implant alignment tool FDA UDI
Device Name: Lateral Positioning Guide FDA UDI
Model / Reference: 10-95-2016 FDA UDI
Description: Lateral Positioning Guide FDA UDI

Identifiers

Primary DI / UDI-DI: 00816127021602 FDA UDI
FDA Product Code: FZX FDA UDI
GMDN Term: Orthopaedic fixation implant alignment tool FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 878.4800 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic fixation implant alignment tool

iNSitu™ Hip System by Nextstep Arthropedix — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic fixation implant alignment tool.

Flux-C Cervical Interbody — ULRICH MEDICAL USA, INC. · Class II
EVOS — Smith & Nephew, Inc. · Class II
“Paonan” Orthopedic Manual Surgical Instrument (Non-Sterile) — Paonan Biotech Co., Ltd. · Class I
U1™ Hip — UNITED ORTHOPEDIC CORP. · Class I
U2™ Knee — UNITED ORTHOPEDIC CORP. · Class I
U-Motion II — UNITED ORTHOPEDIC CORP. · Class I
Flux-C Cervical Interbody — ULRICH MEDICAL USA, INC. · Class II
Easyspine — Ldr Spine USA · Class I

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: Nextstep Arthropedix

Sources (1)

FDA UDI f5d5cd94-1541-4cb3-90b2-1e94cb8c71d7 34 fields · synced May 30, 2026