EXPert Nail

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name: EXPert Nail FDA UDI
Generic Name: Bone nail end-cap FDA UDI
Device Name: 16MM TI END CAP T40 STARDRIVE 5MM EXT-STER/FEMORAL NAILS-EX FDA UDI
Model / Reference: 04.003.006S FDA UDI
Description: 16MM TI END CAP T40 STARDRIVE 5MM EXT-STER/FEMORAL NAILS-EX FDA UDI

Identifiers

Catalog Number: 04003006S FDA UDI
Primary DI / UDI-DI: 10886982081407 FDA UDI
510(k) Number: K033618 FDA UDI
K040336 FDA UDI
FDA Product Code: HSB FDA UDI
HWC FDA UDI
GMDN Term: Bone nail end-cap FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 FDA UDI
888.3040 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

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone nail end-cap

EXPert Nail by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Bone nail end-cap.

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PEDIATRIC LOCKING NAIL SYSTEM — Biomet Orthopedics, Inc. · Class II
PNP Femur — ORTHOPEDIATRICS CORP. · Class II
PNP Femur — ORTHOPEDIATRICS CORP. · Class II
PTN PERITROCHANTERIC NAIL — Biomet Orthopedics, Inc. · Class II

Cleared under the same submission

K033618 also covers:

K040336 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: Synthes

Sources (1)

FDA UDI d97942cf-ffec-4ae7-bc3a-ef905c9e3c93 36 fields · synced Jun 8, 2026