Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ZIMMER MIS LIGHT

K-Number: K080367 · 2008-02-22

ApplicantZimmer Spine, Inc.
Decision Date2008-02-22
Product CodeFST
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ZIMMER MIS LIGHT is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer Spine, Inc.. It received FDA 510(k) clearance on 2008-02-22 under 510(k) number K080367. The device is classified under product code FST. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZIMMER MIS LIGHT?

ZIMMER MIS LIGHT is a medical device that received FDA 510(k) clearance on 2008-02-22. The listed applicant is Zimmer Spine, Inc.. The 510(k) number is K080367.

When did ZIMMER MIS LIGHT receive FDA 510(k) clearance?

ZIMMER MIS LIGHT received FDA 510(k) clearance on 2008-02-22, under 510(k) number K080367.

Who is the listed applicant for ZIMMER MIS LIGHT?

The FDA 510(k) record lists Zimmer Spine, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZIMMER MIS LIGHT?

The FDA product code for ZIMMER MIS LIGHT is FST.

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 Zimmer Spine, Inc. 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.

K153631Zimmer Virage OCT Spinal Fixation SystemK132790INFIX ANTERIOR LUMBAR SYSTEMK133291ST360 DEGREES SPINAL FIXATION SYSTEMK133086TITLE 2 POLYAXIAL SPINAL SYSTEMK132884PATHFINDER NXT MINIMALLY INVASIVE PEDICLE SCREW SYSTEMK131980SEQUOIA PEDICLE SCREW SYSTEM INCLUDING SPEEDLINK II TRANSVERSE CONNECTOR SYSTEM

View all 26 devices →

Related Devices (Code: FST)

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.

K200874TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal EndInnovasis, Inc.K122637LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999Stryker SpineK113697EIGR SURGICAL ILLUMINATION SYSTEMInvuity, Inc.K113330CABLECAPSensormedK102266ISOLED AC-POWERED LED HEADLIGHT SYSTEMIsolux, LLCK101496CABLECAP MODEL: WLF, STZ, ACMSensormed

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.

↑