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)

ReConnex Pre-Sutured Tendon

K-Number: K170957 · 2018-03-20

ApplicantAllosource
Decision Date2018-03-20
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ReConnex Pre-Sutured Tendon is the device name listed in this FDA 510(k) record. The listed applicant is Allosource. It received FDA 510(k) clearance on 2018-03-20 under 510(k) number K170957. The device is classified under product code GAT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ReConnex Pre-Sutured Tendon?

ReConnex Pre-Sutured Tendon is a medical device that received FDA 510(k) clearance on 2018-03-20. The listed applicant is Allosource. The 510(k) number is K170957.

When did ReConnex Pre-Sutured Tendon receive FDA 510(k) clearance?

ReConnex Pre-Sutured Tendon received FDA 510(k) clearance on 2018-03-20, under 510(k) number K170957.

Who is the listed applicant for ReConnex Pre-Sutured Tendon?

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

What is the FDA product code for ReConnex Pre-Sutured Tendon?

The FDA product code for ReConnex Pre-Sutured Tendon is GAT.

Other records listing Allosource 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.

K213046AceConnex Pre-Sutured Fascia

Related Devices (Code: GAT)

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.

K261021EasyWhip FamilyWinter Innovations, Inc.K260775Polyethylene;Polyethylene Fusion;Polyethylene OrthoTape™Teleflex Medical, LLCK254275HyperSuture All Green Extension LineThreadstone, LLCK254188Meniscus VersaflexGM Dos Reis Industria e Comercio Ltda.K253145Pre-Sutured TendonRti Surgical, Inc.K253024ProZip Knotless ImplantRiverpoint Medical

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.

↑