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)

SMV Scientific K-Wire and Pins

K-Number: K182171 · 2018-10-25

ApplicantSummit Medventures
Decision Date2018-10-25
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SMV Scientific K-Wire and Pins is the device name listed in this FDA 510(k) record. The listed applicant is Summit Medventures. It received FDA 510(k) clearance on 2018-10-25 under 510(k) number K182171. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMV Scientific K-Wire and Pins?

SMV Scientific K-Wire and Pins is a medical device that received FDA 510(k) clearance on 2018-10-25. The listed applicant is Summit Medventures. The 510(k) number is K182171.

When did SMV Scientific K-Wire and Pins receive FDA 510(k) clearance?

SMV Scientific K-Wire and Pins received FDA 510(k) clearance on 2018-10-25, under 510(k) number K182171.

Who is the listed applicant for SMV Scientific K-Wire and Pins?

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

What is the FDA product code for SMV Scientific K-Wire and Pins?

The FDA product code for SMV Scientific K-Wire and Pins is JDW.

Related Devices (Code: JDW)

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.

K260073XT3 System; XT3 System, Mini; XT3 System, 40mm; XT3 System, Mini, 40mmBiodynamik, Inc.K250316Meduloc Intramedullary Fracture Fixation (IFF) SystemMeduloc, LLCK241357XT3 SystemBiodynamik, Inc.K223112MAVERICK Mini External Fixation SystemSmith & Nephew, Inc.K213874MAVERICK External Fixation SystemSmith & Nephew, Inc.K211508Steinmann Pins and Kirschner WiresStryker GmbH

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.

↑