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Pinnacle

FDA UDI

Class I (US FDA UDI)

by Depuy (ireland)

Identity

Trade Name
PINNACLE FDA UDI
Generic Name
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI
Device Name
PINNACLE CERAMIC LINER INSERTER GRIPPER 54mm FDA UDI
Model / Reference
2218-10-054 FDA UDI
Description
PINNACLE CERAMIC LINER INSERTER GRIPPER 54mm FDA UDI

Identifiers

Catalog Number
221810054 FDA UDI
Primary DI / UDI-DI
10603295457220 FDA UDI
FDA Product Code
HXO FDA UDI
GMDN Term
Orthopaedic inorganic implant inserter/extractor, reusable FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
888.4540 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

No

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

Yes

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: Orthopaedic inorganic implant inserter/extractor, reusable

Pinnacle by Depuy (ireland) — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic inorganic implant inserter/extractor, reusable.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Depuy (ireland)

Sources (1)

  • FDA UDI 75fb196c-3ce2-4930-9c41-653730b325af 35 fields · synced Jun 1, 2026