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FDA 510(k)

SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY

K-Number: K954717 · 1997-01-22

ApplicantSodem Diffusion SA
Decision Date1997-01-22
Product CodeHBB
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY is the device name listed in this FDA 510(k) record. The listed applicant is Sodem Diffusion SA. It received FDA 510(k) clearance on 1997-01-22 under 510(k) number K954717. The device is classified under product code HBB. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY?

SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY is a medical device that received FDA 510(k) clearance on 1997-01-22. The listed applicant is Sodem Diffusion SA. The 510(k) number is K954717.

When did SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY receive FDA 510(k) clearance?

SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY received FDA 510(k) clearance on 1997-01-22, under 510(k) number K954717.

Who is the listed applicant for SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY?

The FDA 510(k) record lists Sodem Diffusion SA as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY?

The FDA product code for SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STERNOTOMY is HBB.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Sodem Diffusion SA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K955174SODEM HIGH SPEED SYSTEM FOR NEUROSURGERY & MEDIAN STYERNOTOMYK954080SODEM HIGH SPEED SYSTEM

Related Devices (Code: HBB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253772Velocity Alpha MR High Speed Surgical Drill SystemAdeor Medical AGK172907ELAN 4 Air Motor SystemAesculap, Inc.K163182Medtronic Legend Pneumatic; MR7 Pneumatic; Triton Pneumatic Drill System incorporating various Pneumatic Handpieces; Attachments; Surgical Dissecting Tools; and System AccessoriesMedtronic Powered Surgical SolutionsK101168LEGEND POWER ADAPTER MODEL: 6475000Medtronic Sofamor DanekK093361SYNTHES AIR PEN DRIVE (APD) SYSTEMSynthes (Usa)K090112MIDAS REX MR7 PNEUMATIC HIGH SPEED SYSTEM, MODELS PM700, PM710, PC700, PC710, PC720, PA700Medtronic Powered Surgical Solutions

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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