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FDA 510(k)

OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR

K-Number: K913559 · 1991-11-07

ApplicantOsteo AG
Decision Date1991-11-07
Product CodeHSZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR is the device name listed in this FDA 510(k) record. The listed applicant is Osteo AG. It received FDA 510(k) clearance on 1991-11-07 under 510(k) number K913559. 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 OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR?

OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR is a medical device that received FDA 510(k) clearance on 1991-11-07. The listed applicant is Osteo AG. The 510(k) number is K913559.

When did OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR receive FDA 510(k) clearance?

OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR received FDA 510(k) clearance on 1991-11-07, under 510(k) number K913559.

Who is the listed applicant for OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR?

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

What is the FDA product code for OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR?

The FDA product code for OSTEO COMPLETE PNEUMATIC DRILL-OSCILAIR is HSZ.

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Other records listing Osteo AG 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.

K933340OSTEO INTERLOCKING-COMPRESSION NAILK922194OSTEO STEINMANN PINK922195OSTEO FEMORAL NAILK922196OSTEO TIBIA NAILK922193OSTEO KIRSCHNER WIREK920149OSTEO EX-FI-RE

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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.

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