Sirius

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: SIRIUS FDA UDI
Generic Name: Orthopaedic broach FDA UDI
Model / Reference: 31-149107 FDA UDI

Identifiers

Catalog Number: 31-149107 FDA UDI
Primary DI / UDI-DI: 00880304543737 FDA UDI
510(k) Number: K130610 FDA UDI
FDA Product Code: LPH FDA UDI
KWL FDA UDI
PBI FDA UDI
MEH FDA UDI
KWZ FDA UDI
OQG FDA UDI
JDI FDA UDI
LZY FDA UDI
JDG FDA UDI
OQI FDA UDI
KWY FDA UDI
LZO FDA UDI
OQH FDA UDI
GMDN Term: Orthopaedic broach FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3358 FDA UDI
888.3360 FDA UDI
888.3310 FDA UDI
888.3353 FDA UDI
888.3350 FDA UDI
888.3390 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Orthopaedic broach

Sirius by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic broach.

EcoFit® broach for short stem 133° — implantcast GmbH · Class I
PyroCarbon PIP Total Joint System — Smith & Nephew, Inc. · Class I
INSTRUMENT — Howmedica Osteonics Corp. · Class I
Equinoxe — Exactech, Inc. · Class II
Anthology — Smith & Nephew, Inc. · Class I
Affinity J (Instruments for Microscope) — MEDTRONIC SOFAMOR DANEK, INC. · Class I
iNSitu™ Hip System — Nextstep Arthropedix · Class I
TEMA Elbow — Limacorporate · Class II

Cleared under the same submission

K130610 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Biomet Orthopedics, Inc.

Sources (1)

FDA UDI 5504411a-23c6-4068-9323-a1a305d5852a 36 fields · synced Jun 1, 2026