intellijoint HIP®

FDA UDI

Class II (US FDA UDI)

by Intellijoint Surgical Inc

Identity

Trade Name: intellijoint HIP® FDA UDI
Generic Name: Orthopaedic stereotactic surgery system FDA UDI
Device Name: Rod, Washer, 138 mm FDA UDI
Model / Reference: 000-0280 FDA UDI
Description: Rod, Washer, 138 mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00628184002803 FDA UDI
FDA Product Code: OLO FDA UDI
GMDN Term: Orthopaedic stereotactic surgery system FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 882.4560 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

MRI Safety

MR Unsafe FDA UDI

Category: Orthopaedic stereotactic surgery system

intellijoint HIP® by Intellijoint Surgical Inc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Intellijoint Surgical Inc

Sources (1)

FDA UDI 659fb4b4-2c32-4c05-a422-0bee3543abb9 34 fields · synced May 30, 2026