Intramedullary Systems

FDA 510(k) K930972 · Baumer Ortopedia , Ltd.

Substantially Equivalent

510(k) numberK930972

Submission

Device name
Intramedullary Systems
Applicant
Baumer Ortopedia , Ltd.
Mogi Mirim-Sp-Brasil, BR
Received
February 24, 1993
Decision date
March 29, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
HSB – Rod, Fixation, Intramedullary And Accessories
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3020
Specialty
Orthopedic
Implant
Yes

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K253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)HSB · Traditional Suzhou and Science & Technology Development Corp.06/18/2026SE
K253155Fule Metallic Lockable Intramedullary Nail SystemsHSB · Traditional Beijing Fule Science & Technology Development…06/17/2026SE
K253046HERA Interlocking Intramedullary Nailing SystemHSB · Traditional ZheJiang Decans Medical Devices Co., Ltd.06/16/2026SE
K260146Fitbone® Transport and Lengthening SystemHSB · Traditional Orthofix Srl05/19/2026SE
K253991Fitbone™ Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAAHSB · Traditional Orthofix Srl05/08/2026SE
K261043AUTOBAHN™ Nailing SystemHSB · Special Globus Medical, Inc.04/24/2026SE
K252016Arthrex Humeral NailsHSB · Traditional Arthrex, Inc.03/20/2026SE
K252961Fusion FibFix NailHSB · Traditional Fusion Orthopedics USA, LLC03/18/2026SE

More from Fusion Orthopedics USA, LLC

510(k)DeviceDecision
K930966Baumer PlatesHRS · Traditional 04/25/1994SE
K930969Baumer PinsHTY · Traditional 03/29/1994SE
K930967Baumer StaplesJDR · Traditional 03/07/1994SE
K930970Baumer ScrewsHWC · Traditional 01/07/1994SE

Questions and answers

When was Intramedullary Systems cleared by the FDA?

Intramedullary Systems (K930972) received a 510(k) decision of Substantially Equivalent on March 29, 1994, 398 days after the submission was received.

What is the product code of K930972?

The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.