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iNSitu Total Hip System

FDA UDI

Class II (US FDA UDI)

by Nextstep Arthropedix

Identity

Trade Name
iNSitu Total Hip System FDA UDI
Generic Name
Uncoated hip femur prosthesis, modular FDA UDI
Device Name
Cemented Femoral Stem, Size 14, Lateralized FDA UDI
Model / Reference
10-16-0014 FDA UDI
Description
Cemented Femoral Stem, Size 14, Lateralized FDA UDI

Identifiers

Primary DI / UDI-DI
00816127024924 FDA UDI
FDA Product Code
LZO FDA UDI
OQG FDA UDI
OQI FDA UDI
GMDN Term
Uncoated hip femur prosthesis, modular FDA UDI

Classification

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

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Ethylene Oxide FDA UDI

Category: Uncoated hip femur prosthesis, modular

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

Similar devices

Also classified as Uncoated hip femur prosthesis, modular.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Nextstep Arthropedix

Sources (1)

  • FDA UDI 34586a9a-dd87-4a6b-b3dd-bb6868c37127 33 fields · synced Jun 8, 2026