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)

CAPRI Corpectomy Cage System

K-Number: K211320 · 2022-02-24

ApplicantK2m, Inc.
Decision Date2022-02-24
Product CodePLR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CAPRI Corpectomy Cage 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 2022-02-24 under 510(k) number K211320. The device is classified under product code PLR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAPRI Corpectomy Cage System?

CAPRI Corpectomy Cage System is a medical device that received FDA 510(k) clearance on 2022-02-24. The listed applicant is K2m, Inc.. The 510(k) number is K211320.

When did CAPRI Corpectomy Cage System receive FDA 510(k) clearance?

CAPRI Corpectomy Cage System received FDA 510(k) clearance on 2022-02-24, under 510(k) number K211320.

Who is the listed applicant for CAPRI Corpectomy Cage 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 CAPRI Corpectomy Cage System?

The FDA product code for CAPRI Corpectomy Cage System is PLR.

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 InstrumentsK202528Cannulated Power Driver AttachmentK201006K2M Navigation InstrumentsK193203MOJAVE Expandable Interbody System

View all 43 devices →

Related Devices (Code: PLR)

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.

K252822Atlas Spine HiRISE™ Expandable Cervical-p Corpectomy ImplantAtlas Spine, Inc.K252560Atlas Spine HiRISE™ Expandable Cervical Corpectomy SystemAtlas Spine, Inc.K232481RIGEL™ 3DR Anterior Cervical Corpectomy SystemMiRus, LLCK221542Galileo Vertebral Body Replacement DeviceBright SpineK212126MediExpand Cervical Expandable VBR SystemCmf Medicon Surgical, Inc.K192145Galileo Vertebral Body Replacement DeviceBright Spine

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.

↑