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)

MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE

K-Number: K033718 · 2004-02-12

ApplicantArthrotek, Inc.
Decision Date2004-02-12
Product CodeGAT
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is Arthrotek, Inc.. It received FDA 510(k) clearance on 2004-02-12 under 510(k) number K033718. 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 MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE?

MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE is a medical device that received FDA 510(k) clearance on 2004-02-12. The listed applicant is Arthrotek, Inc.. The 510(k) number is K033718.

When did MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE receive FDA 510(k) clearance?

MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE received FDA 510(k) clearance on 2004-02-12, under 510(k) number K033718.

Who is the listed applicant for MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE?

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

What is the FDA product code for MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE?

The FDA product code for MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE is GAT.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Arthrotek, Inc. 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.

K061776ARTHROTEK MAXFIRE MENISCAL REPAIR DEVICEK0618012.8 & 3.5MM LACTOSCREW SUTURE ANCHORSK061657HITCH LACTOSORB SUTURE ANCHORK061389ALLTHREAD LACTOSORB SUTURE ANCHORK060693MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHORK053461EZLOC FEMORAL FIXATION DEVICE

View all 17 devices →

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.

K253910Stitch - Suture Wires and TapesGM Dos Reis Industria e Comercio Ltda.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.

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.

↑