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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
Femoral Disc, Round, Sterile FDA UDI
Model / Reference
000-0376 FDA UDI
Description
Femoral Disc, Round, Sterile FDA UDI

Identifiers

Primary DI / UDI-DI
00628184003763 FDA UDI
510(k) Number
K172849 FDA UDI
K191507 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
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

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

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

Cleared under the same submission

K172849 also covers:

K191507 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Intellijoint Surgical Inc

Sources (1)

  • FDA UDI 7ab696a0-f4e8-4963-af83-fd45842ae977 36 fields · synced Jun 1, 2026