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)

RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS

K-Number: K880074 · 1988-03-25

ApplicantRomano Surgical Instrumentation, Inc.
Decision Date1988-03-25
Product CodeHSZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS is the device name listed in this FDA 510(k) record. The listed applicant is Romano Surgical Instrumentation, Inc.. It received FDA 510(k) clearance on 1988-03-25 under 510(k) number K880074. The device is classified under product code HSZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS?

RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS is a medical device that received FDA 510(k) clearance on 1988-03-25. The listed applicant is Romano Surgical Instrumentation, Inc.. The 510(k) number is K880074.

When did RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS receive FDA 510(k) clearance?

RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS received FDA 510(k) clearance on 1988-03-25, under 510(k) number K880074.

Who is the listed applicant for RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS?

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

What is the FDA product code for RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS?

The FDA product code for RSI GLENOID ARCUATE BONE DRILL W/DISP. FLEXI-BITS is HSZ.

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 Romano Surgical Instrumentation, 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.

K885229MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS

Related Devices (Code: HSZ)

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.

K991588EMS SWISS ORTHOCLAST(Ems Sa) Electro Medical SystemsK972860CURVTEK TSR SYSTEMBiolectron, Inc.K970345ALIGNMENT INSTRUMENTRichard Wolf Medical Instruments Corp.K955084ASPACH 65,000 (MODIFICATION)The Anspach Effort, Inc.K954080SODEM HIGH SPEED SYSTEMSodem Diffusion SAK944590ETHICON DRILL BIT AND DRILL GUIDEETHICON, 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.

↑