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)

SILVER OSTEOTOME

K-Number: K772374 · 1978-03-09

ApplicantEdward Weck, Inc.
Decision Date1978-03-09
Product CodeKDG
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SILVER OSTEOTOME is the device name listed in this FDA 510(k) record. The listed applicant is Edward Weck, Inc.. It received FDA 510(k) clearance on 1978-03-09 under 510(k) number K772374. The device is classified under product code KDG. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILVER OSTEOTOME?

SILVER OSTEOTOME is a medical device that received FDA 510(k) clearance on 1978-03-09. The listed applicant is Edward Weck, Inc.. The 510(k) number is K772374.

When did SILVER OSTEOTOME receive FDA 510(k) clearance?

SILVER OSTEOTOME received FDA 510(k) clearance on 1978-03-09, under 510(k) number K772374.

Who is the listed applicant for SILVER OSTEOTOME?

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

What is the FDA product code for SILVER OSTEOTOME?

The FDA product code for SILVER OSTEOTOME is KDG.

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 Edward Weck, 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.

K915378WECK TROCARK914690LM15(TM), CATALOG NUMBER - 523821K911915HEMOCLIP IIK914470PNEUMO-SEAL(TM)K911272ENDOSCOPIC NEEDLHOLDER CAT. NUMBER 114705K902108HEM-O-LOK(TM)

View all 140 devices →

Related Devices (Code: KDG)

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.

K952678STA-CLEAR ALCOHOL-FREE ENDOSCOPIC ANTI-FOG KITAvail-Southwest DivisionK952200OMNI-JUGWaterstone Medical, Inc.K894785SURGICAL CHISEL/OSTEOTOMEFdt Precision Machine Co., Inc.K891471SIL-MED WASTE FLUID DUMP BAGSil-Med Corp.K872947POREX QUALITY PLASTIC SURGERY INSTRUMENTSPorex MedicalK872092OSTEOTOME SET, HOKE, STRAIGHT, SET OF 5Military Engineering, 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.

↑