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FDA 510(k)

GUILLOTINE BLADE

K-Number: K831772 · 1983-07-07

ApplicantOrtho Pared Instruments, Inc.
Decision Date1983-07-07
Product CodeHTZ
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

GUILLOTINE BLADE is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Pared Instruments, Inc.. It received FDA 510(k) clearance on 1983-07-07 under 510(k) number K831772. The device is classified under product code HTZ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GUILLOTINE BLADE?

GUILLOTINE BLADE is a medical device that received FDA 510(k) clearance on 1983-07-07. The listed applicant is Ortho Pared Instruments, Inc.. The 510(k) number is K831772.

When did GUILLOTINE BLADE receive FDA 510(k) clearance?

GUILLOTINE BLADE received FDA 510(k) clearance on 1983-07-07, under 510(k) number K831772.

Who is the listed applicant for GUILLOTINE BLADE?

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

What is the FDA product code for GUILLOTINE BLADE?

The FDA product code for GUILLOTINE BLADE is HTZ.

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 Ortho Pared Instruments, 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.

K820225MENISCUS EXTRACTORK820226UNIVERSALL DRILL GUIDEK812566UNIVERSAL SUTURE PASSER

Related Devices (Code: HTZ)

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.

K933933CEBOPLANESynvasive Technology, Inc.K931737HEDLEYL INTRAMEDULLARY PREPARATION BRUSHSynvasive Technology, Inc.K87088245 DEGREE SHAVERBowen & Company, Inc.K853678KAMBIN SPINAL INSTRUMENT SETPilling Co.K850423CONCEPT SUCTION SLEEVEConcept, Inc.K850527ARTHROSCOPY SUCTION BIOPSY PUNCHT. Korossurgical 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.

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