Broach Set SPX1

FDA UDI

Class II (US FDA UDI)

by Ecential Robotics

Identity

Trade Name: Broach Set SPX1 FDA UDI
Generic Name: Orthopaedic bone pin, non-bioabsorbable FDA UDI
Model / Reference: A01021 FDA UDI

Identifiers

Primary DI / UDI-DI: 03701311500995 FDA UDI
510(k) Number: K202547 FDA UDI
FDA Product Code: OXO FDA UDI
JAA FDA UDI
OWB FDA UDI
GMDN Term: Orthopaedic bone pin, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 892.1650 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

Category: Orthopaedic bone pin, non-bioabsorbable

Broach Set SPX1 by Ecential Robotics — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Orthopaedic bone pin, non-bioabsorbable.

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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

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: Ecential Robotics

Sources (1)

FDA UDI d5f7c89b-84bf-406a-91f9-110c21e92ace 34 fields · synced May 30, 2026