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)

ORTHOBLEND POWERED BONE MILL

K-Number: K860356 · 1986-07-08

ApplicantZimmer, Inc.
Decision Date1986-07-08
Product CodeLYS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOBLEND POWERED BONE MILL is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1986-07-08 under 510(k) number K860356. 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 ORTHOBLEND POWERED BONE MILL?

ORTHOBLEND POWERED BONE MILL is a medical device that received FDA 510(k) clearance on 1986-07-08. The listed applicant is Zimmer, Inc.. The 510(k) number is K860356.

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

ORTHOBLEND POWERED BONE MILL received FDA 510(k) clearance on 1986-07-08, under 510(k) number K860356.

Who is the listed applicant for ORTHOBLEND POWERED BONE MILL?

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

What is the FDA product code for ORTHOBLEND POWERED BONE MILL?

The FDA product code for ORTHOBLEND POWERED 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 Zimmer, 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.

K262955OsseoFit Stemless Shoulder SystemK260831Z1 Hip SystemK261683Augment Off-Axis Instrument SystemK251840Zimmer® Persona® Personalized Knee SystemK260182Avenir® Müller Stem; Avenir Complete™ Hip SystemK253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

View all 344 devices →

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.

K883183TRACER BONE MILLDe Medica Mfg., 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.

↑