iNSitu™ Hip System

FDA UDI

Class II (US FDA UDI)

by Nextstep Arthropedix

Identity

Trade Name: iNSitu™ Hip System FDA UDI
Generic Name: Acetabulum prosthesis hole plug FDA UDI
Device Name: Screw Hole Cover FDA UDI
Model / Reference: 10-60-0001 FDA UDI
Description: Screw Hole Cover FDA UDI

Identifiers

Primary DI / UDI-DI: 00816127023415 FDA UDI
FDA Product Code: LPH FDA UDI
LZO FDA UDI
OQG FDA UDI
OQI FDA UDI
GMDN Term: Acetabulum prosthesis hole plug FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3358 FDA UDI
888.3353 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

Yes

FDA UDI

Category: Acetabulum prosthesis hole plug

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

Similar devices

Also classified as Acetabulum prosthesis hole plug.

plug — implantcast GmbH · Class II
RINGLOC HIP SYSTEM — Biomet Orthopedics, Inc. · Class II
Trinity Acetabular Hip System — CORIN LTD · Class II
Escalade Acetabular System — ORTHO DEVELOPMENT CORP. · Class II
Continuum® — Zimmer, Inc. · Class II
ORTHOLOC™ 2 Jones Fracture System — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Converge® — Zimmer, Inc. · Class II
R3 — Smith & Nephew, 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

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Manufacturer

Manufacturer: Nextstep Arthropedix

Sources (1)

FDA UDI 7f9f3413-5ad2-40ce-a91e-cdc7ce39acbb 34 fields · synced Jun 1, 2026