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FDA 510(k)

S4 SPINAL SYSTEM

K-Number: K071945 · 2007-09-20

ApplicantAesculap Implant Systems
Decision Date2007-09-20
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

S4 SPINAL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Aesculap Implant Systems. It received FDA 510(k) clearance on 2007-09-20 under 510(k) number K071945. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the S4 SPINAL SYSTEM?

S4 SPINAL SYSTEM is a medical device that received FDA 510(k) clearance on 2007-09-20. The listed applicant is Aesculap Implant Systems. The 510(k) number is K071945.

When did S4 SPINAL SYSTEM receive FDA 510(k) clearance?

S4 SPINAL SYSTEM received FDA 510(k) clearance on 2007-09-20, under 510(k) number K071945.

Who is the listed applicant for S4 SPINAL SYSTEM?

The FDA 510(k) record lists Aesculap Implant Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for S4 SPINAL SYSTEM?

The FDA product code for S4 SPINAL SYSTEM is NKB.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Aesculap Implant Systems 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.

K121879VEGA KNEE SYSTEMK101815ENDURO KNEE SYSTEMK100623AESCULAP IMPLANT SYSTEMS S4 SPINAL SYSTEMK090299BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADSK090657MODIFICATION TO: S4 SPINAL SYSTEM

Related Devices (Code: NKB)

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.

K252139Kentrospine Viktr-MIS® Pedicle screw systemRivarp Medical Pvt., Ltd.K262067iFuse Granite Onyx™ Implant SystemSI-BONE, Inc.K262091FRAXION Spinal Fixation SystemOrtler Global Tibbi Gerecler Anonim SirketiK262193RIVA® Posterior Fixation System with NanoACTIV Surface Technology; RIVA® Anchor Sacroiliac Fixation System with NanoACTIV Surface TechnologyXenix MedicalK262828KHEIRON® Spinal Fixation System, including patient specific K-RODS.M.A.I.OK260362QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)MANTIZ Co., Ltd.

Official Source

View on FDA Database →

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

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