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)

TRACER BONE MILL

K-Number: K883183 · 1988-10-12

ApplicantDe Medica Mfg., Inc.
Decision Date1988-10-12
Product CodeLYS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRACER BONE MILL is the device name listed in this FDA 510(k) record. The listed applicant is De Medica Mfg., Inc.. It received FDA 510(k) clearance on 1988-10-12 under 510(k) number K883183. The device is classified under product code LYS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRACER BONE MILL?

TRACER BONE MILL is a medical device that received FDA 510(k) clearance on 1988-10-12. The listed applicant is De Medica Mfg., Inc.. The 510(k) number is K883183.

When did TRACER BONE MILL receive FDA 510(k) clearance?

TRACER BONE MILL received FDA 510(k) clearance on 1988-10-12, under 510(k) number K883183.

Who is the listed applicant for TRACER BONE MILL?

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

What is the FDA product code for TRACER BONE MILL?

The FDA product code for TRACER BONE MILL is LYS.

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 De Medica Mfg., 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.

K884407TRACER SKELETAL TRACTION PINSK884406TRACER HIP PINNING SYSTEM

Related Devices (Code: LYS)

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.

K860356ORTHOBLEND POWERED BONE MILLZimmer, Inc.K861164OSTEOMILL BONE GRINDERBiodynamic Technologies, Inc.K860016AESCULAP BONE MILLAesculap Instruments Corp.

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.

↑