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FDA 510(k)

Orthopedic Fixation Pin

K-Number: K191803 · 2020-04-14

ApplicantTinavi (Anhui) Medical Technologies Co., Ltd.
Decision Date2020-04-14
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Orthopedic Fixation Pin is the device name listed in this FDA 510(k) record. The listed applicant is Tinavi (Anhui) Medical Technologies Co., Ltd.. It received FDA 510(k) clearance on 2020-04-14 under 510(k) number K191803. 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 Orthopedic Fixation Pin?

Orthopedic Fixation Pin is a medical device that received FDA 510(k) clearance on 2020-04-14. The listed applicant is Tinavi (Anhui) Medical Technologies Co., Ltd.. The 510(k) number is K191803.

When did Orthopedic Fixation Pin receive FDA 510(k) clearance?

Orthopedic Fixation Pin received FDA 510(k) clearance on 2020-04-14, under 510(k) number K191803.

Who is the listed applicant for Orthopedic Fixation Pin?

The FDA 510(k) record lists Tinavi (Anhui) Medical Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Orthopedic Fixation Pin?

The FDA product code for Orthopedic Fixation Pin 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.

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