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)

LIFE SPINE STAND-ALONE SPACER SYSTEM

K-Number: K091301 · 2009-12-15

ApplicantLife Spine
Decision Date2009-12-15
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LIFE SPINE STAND-ALONE SPACER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Life Spine. It received FDA 510(k) clearance on 2009-12-15 under 510(k) number K091301. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIFE SPINE STAND-ALONE SPACER SYSTEM?

LIFE SPINE STAND-ALONE SPACER SYSTEM is a medical device that received FDA 510(k) clearance on 2009-12-15. The listed applicant is Life Spine. The 510(k) number is K091301.

When did LIFE SPINE STAND-ALONE SPACER SYSTEM receive FDA 510(k) clearance?

LIFE SPINE STAND-ALONE SPACER SYSTEM received FDA 510(k) clearance on 2009-12-15, under 510(k) number K091301.

Who is the listed applicant for LIFE SPINE STAND-ALONE SPACER SYSTEM?

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

What is the FDA product code for LIFE SPINE STAND-ALONE SPACER SYSTEM?

The FDA product code for LIFE SPINE STAND-ALONE SPACER SYSTEM is OVD.

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 Life Spine 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.

K182470Plateau Spacer SystemK160169The Life Spine Subtalar Implant SystemK131077LIFE SPINE PLATEAU SPACER SYSTEMK123373NAUTILUS SPINAL SYSTEMK120998SOLSTICE CROSS CONNECTORK111953NAUTILUS SPINAL SYSTEM

View all 33 devices →

Related Devices (Code: OVD)

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.

K262025Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis HAtetracell®-C Titanium Cervical IBF SystemINNO Holdings Inc. DBA InnovasisK261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.

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.

↑