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)

OS2(R)-VP Varisation Staple

K-Number: K153770 · 2016-03-21

ApplicantIn2bones Sas
Decision Date2016-03-21
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OS2(R)-VP Varisation Staple is the device name listed in this FDA 510(k) record. The listed applicant is In2bones Sas. It received FDA 510(k) clearance on 2016-03-21 under 510(k) number K153770. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OS2(R)-VP Varisation Staple?

OS2(R)-VP Varisation Staple is a medical device that received FDA 510(k) clearance on 2016-03-21. The listed applicant is In2bones Sas. The 510(k) number is K153770.

When did OS2(R)-VP Varisation Staple receive FDA 510(k) clearance?

OS2(R)-VP Varisation Staple received FDA 510(k) clearance on 2016-03-21, under 510(k) number K153770.

Who is the listed applicant for OS2(R)-VP Varisation Staple?

The FDA 510(k) record lists In2bones Sas as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OS2(R)-VP Varisation Staple?

The FDA product code for OS2(R)-VP Varisation Staple is JDR.

Other records listing In2bones Sas 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.

K231699QUANTUM® Patient Specific Instrumentation (PSI) SystemK230313QUANTUM Patient Specific Instrumentation (PSI) SystemK211883QUANTUM® Patient Specific Instrumentation (PSI) SystemK191380Quantum® Total Ankle ProsthesisK173811TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis SystemK173616DIP Arthrodesis System

View all 14 devices →

Related Devices (Code: JDR)

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.

K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical ConceptsK242415TMC Compression Implant SystemTreace Medical Concepts

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.

↑