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FDA 510(k)

FRONT RADIUS CUTTER

K-Number: K841620 · 1984-09-20

ApplicantPlastafil, Inc.
Decision Date1984-09-20
Product CodeHTX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FRONT RADIUS CUTTER is the device name listed in this FDA 510(k) record. The listed applicant is Plastafil, Inc.. It received FDA 510(k) clearance on 1984-09-20 under 510(k) number K841620. The device is classified under product code HTX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRONT RADIUS CUTTER?

FRONT RADIUS CUTTER is a medical device that received FDA 510(k) clearance on 1984-09-20. The listed applicant is Plastafil, Inc.. The 510(k) number is K841620.

When did FRONT RADIUS CUTTER receive FDA 510(k) clearance?

FRONT RADIUS CUTTER received FDA 510(k) clearance on 1984-09-20, under 510(k) number K841620.

Who is the listed applicant for FRONT RADIUS CUTTER?

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

What is the FDA product code for FRONT RADIUS CUTTER?

The FDA product code for FRONT RADIUS CUTTER is HTX.

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 Plastafil, 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.

K841621BACK RADIUS CUTTERK841625HOOKK841617STROVER HOOKK841626PUNCHK841629DRILL BITK841627MALLET

View all 13 devices →

Related Devices (Code: HTX)

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.

K874954MANUAL RONGEURSolway, Inc.K841621BACK RADIUS CUTTERPlastafil, Inc.K780397ORTHOPEDIC FORCEPSOrthopedic Equipment Co., Inc.K760325SURGICAL INSTRUMENTS, ORTHOPEDICDepuy, 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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