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FDA 510(k)

MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS

K-Number: K885229 · 1989-09-29

ApplicantRomano Surgical Instrumentation, Inc.
Decision Date1989-09-29
Product CodeHSZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

MODIFIED GLENOID ARCUATE DRILL & 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 1989-09-29 under 510(k) number K885229. 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 MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS?

MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS is a medical device that received FDA 510(k) clearance on 1989-09-29. The listed applicant is Romano Surgical Instrumentation, Inc.. The 510(k) number is K885229.

When did MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS receive FDA 510(k) clearance?

MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS received FDA 510(k) clearance on 1989-09-29, under 510(k) number K885229.

Who is the listed applicant for MODIFIED GLENOID ARCUATE DRILL & 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 MODIFIED GLENOID ARCUATE DRILL & DISP. FLEXI-BITS?

The FDA product code for MODIFIED GLENOID ARCUATE DRILL & 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.

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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.

K880074RSI GLENOID ARCUATE BONE DRILL W/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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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