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)

STERNUM SAW BLADE

K-Number: K802838 · 1980-12-11

ApplicantAmsco Co.
Decision Date1980-12-11
Product CodeGFA
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

STERNUM SAW BLADE is the device name listed in this FDA 510(k) record. The listed applicant is Amsco Co.. It received FDA 510(k) clearance on 1980-12-11 under 510(k) number K802838. The device is classified under product code GFA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STERNUM SAW BLADE?

STERNUM SAW BLADE is a medical device that received FDA 510(k) clearance on 1980-12-11. The listed applicant is Amsco Co.. The 510(k) number is K802838.

When did STERNUM SAW BLADE receive FDA 510(k) clearance?

STERNUM SAW BLADE received FDA 510(k) clearance on 1980-12-11, under 510(k) number K802838.

Who is the listed applicant for STERNUM SAW BLADE?

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

What is the FDA product code for STERNUM SAW BLADE?

The FDA product code for STERNUM SAW BLADE is GFA.

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 Amsco Co. 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.

K912471EAGLE 3000 SDSK854922AMSCO POLARIS SLK833187HALL OSTEONK832945EAGLE 2000 STERILIZER SERIES GAS/AERAK832187HALL OSCILLATORK832186HALL DRILL/REAMER

View all 19 devices →

Related Devices (Code: GFA)

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.

K971978GRAFT HARVESTING SAWBLADESWrightmedicaltechnologyincK954483STRYKER SAGITTAL SAW ATTACHMENTStryker InstrumentsK955229WRIGHT MEDICAL TECHNOLOGY SAWBLADESWrightmedicaltechnologyincK953012DISPOSABLE & REUSABLE SURGICAL CUTTING TOOLSBoston Surgical Products, Inc.K950403SURGICAL SAW BLADESTransidyne General Corp.K940501RE-SHARPENABLE SAW BLADESAdven 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.

↑