FDA 510(k)

MESA AND RANGE SPINAL SYSTEMS

K-Number: K082769 · 2008-12-11

Decision Date2008-12-11

Product CodeKWP

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

MESA AND RANGE SPINAL SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2008-12-11 under 510(k) number K082769. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MESA AND RANGE SPINAL SYSTEMS?

MESA AND RANGE SPINAL SYSTEMS is a medical device that received FDA 510(k) clearance on 2008-12-11. The listed applicant is K2m, Inc.. The 510(k) number is K082769.

When did MESA AND RANGE SPINAL SYSTEMS receive FDA 510(k) clearance?

MESA AND RANGE SPINAL SYSTEMS received FDA 510(k) clearance on 2008-12-11, under 510(k) number K082769.

Who is the listed applicant for MESA AND RANGE SPINAL SYSTEMS?

The FDA 510(k) record lists K2m, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MESA AND RANGE SPINAL SYSTEMS?

The FDA product code for MESA AND RANGE SPINAL SYSTEMS is KWP.

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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing K2m, Inc. as applicant

K260546Q Pedicle Instruments K253545Vulcan Spinal System K252873Q Interbody Instruments K211320CAPRI Corpectomy Cage System K202528Cannulated Power Driver Attachment K201006K2M Navigation Instruments

View all 79 devices →

Related Devices (Code: KWP)

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLC K132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLC K131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARL K131156LANX SPINAL FIXATION SYSTEMLanx, Inc.

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.