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)

Steinmann Pins and Kirschner Wires

K-Number: K211508 · 2021-10-05

ApplicantStryker GmbH
Decision Date2021-10-05
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Steinmann Pins and Kirschner Wires is the device name listed in this FDA 510(k) record. The listed applicant is Stryker GmbH. It received FDA 510(k) clearance on 2021-10-05 under 510(k) number K211508. 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 Steinmann Pins and Kirschner Wires?

Steinmann Pins and Kirschner Wires is a medical device that received FDA 510(k) clearance on 2021-10-05. The listed applicant is Stryker GmbH. The 510(k) number is K211508.

When did Steinmann Pins and Kirschner Wires receive FDA 510(k) clearance?

Steinmann Pins and Kirschner Wires received FDA 510(k) clearance on 2021-10-05, under 510(k) number K211508.

Who is the listed applicant for Steinmann Pins and Kirschner Wires?

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

What is the FDA product code for Steinmann Pins and Kirschner Wires?

The FDA product code for Steinmann Pins and Kirschner Wires is JDW.

Other records listing Stryker GmbH 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.

K261481Pangea Femur Reconstruction SystemK253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemK253202Hoffmann LRF SystemK251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemK250163T2 Alpha Femur Retrograde Nailing SystemK242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating System

View all 164 devices →

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.K210784Extended HA Half PinsSmith & Nephew, 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.

↑