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)

Graftgun Universal Graft Delivery System

K-Number: K180937 · 2018-05-10

ApplicantSurGenTec, LLC
Decision Date2018-05-10
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Graftgun Universal Graft Delivery System is the device name listed in this FDA 510(k) record. The listed applicant is SurGenTec, LLC. It received FDA 510(k) clearance on 2018-05-10 under 510(k) number K180937. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Graftgun Universal Graft Delivery System?

Graftgun Universal Graft Delivery System is a medical device that received FDA 510(k) clearance on 2018-05-10. The listed applicant is SurGenTec, LLC. The 510(k) number is K180937.

When did Graftgun Universal Graft Delivery System receive FDA 510(k) clearance?

Graftgun Universal Graft Delivery System received FDA 510(k) clearance on 2018-05-10, under 510(k) number K180937.

Who is the listed applicant for Graftgun Universal Graft Delivery System?

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

What is the FDA product code for Graftgun Universal Graft Delivery System?

The FDA product code for Graftgun Universal Graft Delivery System is FMF.

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.

NCT06720948The ION Facet Screw System Ambispective EvaluationENROLLING_BY_INVITATIONNCT07784673OsteoFlo HydroFiber Ambispective EvaluationENROLLING_BY_INVITATION

Other records listing SurGenTec, LLC 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.

K262121Ion-L Navigated InstrumentsK261209Ion-LK260329Ion-C Navigation InstrumentsK253604TiLink-L Navigation InstrumentsK251714Ion-CK251720OsteoFlo HydroFiber

View all 29 devices →

Related Devices (Code: FMF)

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.

K253747Disposable Pen Injector (KXYC-03C02, KXYC-03A03)Jiangsu Enjosim Medical Technology Co., Ltd.K260208Ultra-Fine™ SAFETY Insulin Syringeembecta Medical II, LLCK253110Sol-Glide Safety Needle; Sol-Glide Safety Needle with SyringeSol-Millennium Medical, Inc.K260514Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low Dead Space Syringe with Safety NeedleCMT Health PTE., Ltd.K253112Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); Sofjec (Membrane Filter Syringe)Hlb Lifescience Co., Ltd.K252279Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml)Chirana T.Injecta,A.S.

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.

↑