XtraFix®

FDA UDI

Class II (US FDA UDI)

by Zimmer, Inc.

Identity

Trade Name: XtraFix® FDA UDI
Generic Name: Orthopaedic bone pin, non-bioabsorbable FDA UDI
Model / Reference: 00-5204-030-20 FDA UDI

Identifiers

Catalog Number: 00-5204-030-20 FDA UDI
Primary DI / UDI-DI: 00889024080799 FDA UDI
510(k) Number: K131413 FDA UDI
FDA Product Code: JDW FDA UDI
GMDN Term: Orthopaedic bone pin, non-bioabsorbable 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

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Length — 80 Millimeter FDA UDI

Category: Orthopaedic bone pin, non-bioabsorbable

XtraFix® by Zimmer, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic bone pin, non-bioabsorbable.

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KW03-310-18.A — newbox medical GmbH · Class IIb
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IlluminOss — ILLUMINOSS MEDICAL INC. · Class II
CALIBRATED GUIDE WIRE, THREADED TROCAR POINT — Biomet Orthopedics, Inc. · Class II
TRAUMA FIXATION SYSTEMS — Biomet Orthopedics, Inc. · Class II
SMART TSF — Smith & Nephew, Inc. · Class II
KW02-300-20.A — newbox medical GmbH · Class IIb

Cleared under the same submission

K131413 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: Zimmer, Inc.

Sources (1)

FDA UDI 70acc8ed-1e52-47a3-8e32-1b0dcb2e11b9 36 fields · synced Jun 8, 2026