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)

SAHARA Stabilization System

K-Number: K190179 · 2019-10-03

ApplicantK2m, Inc.
Decision Date2019-10-03
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SAHARA Stabilization System is the device name listed in this FDA 510(k) record. The listed applicant is K2m, Inc.. It received FDA 510(k) clearance on 2019-10-03 under 510(k) number K190179. 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 SAHARA Stabilization System?

SAHARA Stabilization System is a medical device that received FDA 510(k) clearance on 2019-10-03. The listed applicant is K2m, Inc.. The 510(k) number is K190179.

When did SAHARA Stabilization System receive FDA 510(k) clearance?

SAHARA Stabilization System received FDA 510(k) clearance on 2019-10-03, under 510(k) number K190179.

Who is the listed applicant for SAHARA Stabilization System?

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 SAHARA Stabilization System?

The FDA product code for SAHARA Stabilization System is OVD.

Other records listing K2m, 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.

K260546Q Pedicle InstrumentsK253545Vulcan Spinal SystemK252873Q Interbody InstrumentsK211320CAPRI Corpectomy Cage SystemK202528Cannulated Power Driver AttachmentK201006K2M Navigation Instruments

View all 43 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.

K261408SABER-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.K253401SCRIPT™ Implant SystemGlobus Medical, 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.

↑