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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 trial, prefabricated, reusable FDA UDI
Device Name
Neutral Liner Trial Size 48 x 32mm ID FDA UDI
Model / Reference
10-85-3248 FDA UDI
Description
Neutral Liner Trial Size 48 x 32mm ID FDA UDI

Identifiers

Primary DI / UDI-DI
00816127021152 FDA UDI
FDA Product Code
LPH FDA UDI
LZO FDA UDI
OQG FDA UDI
OQI FDA UDI
GMDN Term
Acetabulum prosthesis trial, prefabricated, reusable 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Category: Acetabulum prosthesis trial, prefabricated, reusable

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 trial, prefabricated, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nextstep Arthropedix

Sources (1)

  • FDA UDI 0390b70b-7e0d-46a8-a876-1dfb1828cd09 34 fields · synced May 30, 2026