Zavation STRAIGHT ROD

FDA UDI

Class I (US FDA UDI)

by Zavation

Identity

Trade Name: Zavation STRAIGHT ROD FDA UDI
Generic Name: Orthopaedic bone pin, non-bioabsorbable FDA UDI
Device Name: STRAIGHT ROD FDA UDI
Model / Reference: 381-S130 FDA UDI
Description: STRAIGHT ROD FDA UDI

Identifiers

Primary DI / UDI-DI: 00197157049904 FDA UDI
510(k) Number: K222614 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Orthopaedic bone pin, non-bioabsorbable 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

FDA UDI

Single Use

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: Orthopaedic bone pin, non-bioabsorbable

Zavation STRAIGHT ROD by Zavation — Class I — 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
XtraFix® External Fixation System — Zimmer, 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

Cleared under the same submission

K222614 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 I	Pending data

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Manufacturer

Manufacturer: Zavation

Sources (1)

FDA UDI 89e6bbd9-9c10-46bf-8696-8779a6b23b69 35 fields · synced Jun 1, 2026