Apex

FDA UDI

Class II (US FDA UDI)

by Stryker Corp.

Identity

Trade Name: APEX FDA UDI
Generic Name: Bone nail end-cap FDA UDI
Device Name: Disposable end caps (Brown) Apex Dia 3mm FDA UDI
Model / Reference: 5047-1-030 FDA UDI
Description: Disposable end caps (Brown) Apex Dia 3mm FDA UDI

Identifiers

Catalog Number: 5047-1-030 FDA UDI
Primary DI / UDI-DI: 07613327081848 FDA UDI
510(k) Number: K861766 FDA UDI
FDA Product Code: JDW FDA UDI
GMDN Term: Bone nail end-cap FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone nail end-cap

Apex by Stryker Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cleared under the same submission

K861766 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: Stryker Corp.

Sources (1)

FDA UDI dee4a0ee-4a6c-4f74-8a9d-6a52338c3603 36 fields · synced May 30, 2026