Pinnacle

FDA UDI

Class II (US FDA UDI)

by Depuy Orthopaedics, Inc.

Identity

Trade Name: PINNACLE FDA UDI
Generic Name: Acetabular shell FDA UDI
Device Name: PINNACLE HIP SOLUTIONS POROCOAT ACETABULAR SHELL BANTAM 46mm OD FDA UDI
Model / Reference: 1217-20-046 FDA UDI
Description: PINNACLE HIP SOLUTIONS POROCOAT ACETABULAR SHELL BANTAM 46mm OD FDA UDI

Identifiers

Catalog Number: 121720046 FDA UDI
Primary DI / UDI-DI: 10603295009597 FDA UDI
510(k) Number: K000306 FDA UDI
K001534 FDA UDI
K900832 FDA UDI
K961186 FDA UDI
K983491 FDA UDI
FDA Product Code: LPH FDA UDI
JDI FDA UDI
GMDN Term: Acetabular shell FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3358 FDA UDI
888.3350 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

FDA UDI

Category: Acetabular shell

Pinnacle by Depuy Orthopaedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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InSitu Hip System — Nextstep Arthropedix · Class II
REFLECTION — Smith & Nephew, Inc. · Class II
Regenerex® Ringloc®+ Hip System — Biomet Orthopedics, Inc. · Class II

Cleared under the same submission

K900832 also covers:

K961186 also covers:

K983491 also covers:

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: Depuy Orthopaedics, Inc.

Sources (1)

FDA UDI 2a431104-338f-4de1-bf86-89f2c36adc1b 36 fields · synced Jun 8, 2026