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)

Syntec Non-Sterile Steinmann Pins System

K-Number: K200933 · 2020-05-05

ApplicantSyntec Scientific Corporation
Decision Date2020-05-05
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Syntec Non-Sterile Steinmann Pins System is the device name listed in this FDA 510(k) record. The listed applicant is Syntec Scientific Corporation. It received FDA 510(k) clearance on 2020-05-05 under 510(k) number K200933. 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 Syntec Non-Sterile Steinmann Pins System?

Syntec Non-Sterile Steinmann Pins System is a medical device that received FDA 510(k) clearance on 2020-05-05. The listed applicant is Syntec Scientific Corporation. The 510(k) number is K200933.

When did Syntec Non-Sterile Steinmann Pins System receive FDA 510(k) clearance?

Syntec Non-Sterile Steinmann Pins System received FDA 510(k) clearance on 2020-05-05, under 510(k) number K200933.

Who is the listed applicant for Syntec Non-Sterile Steinmann Pins System?

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

What is the FDA product code for Syntec Non-Sterile Steinmann Pins System?

The FDA product code for Syntec Non-Sterile Steinmann Pins System is JDW.

Other records listing Syntec Scientific Corporation 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.

K202790Syntec Orthodontic Mini Screw Extended SystemK202935Syntec Femoral Nail Extended SystemK191617Syntec Tibial Nail SystemK181296Syntec Femoral Nail SystemK161327SYNTEC HUMERAL NAIL SYSTEM

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.

↑