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FDA 510(k)

R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM

K-Number: K961496 · 1996-06-28

ApplicantHowmedica, Inc.
Decision Date1996-06-28
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica, Inc.. It received FDA 510(k) clearance on 1996-06-28 under 510(k) number K961496. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM?

R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 1996-06-28. The listed applicant is Howmedica, Inc.. The 510(k) number is K961496.

When did R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM receive FDA 510(k) clearance?

R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM received FDA 510(k) clearance on 1996-06-28, under 510(k) number K961496.

Who is the listed applicant for R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM?

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

What is the FDA product code for R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM?

The FDA product code for R.R.P.S. RADIUS RECONSTRUTION PLATING SYSTEM is HRS.

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Other records listing Howmedica, Inc. as applicant

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Related Devices (Code: HRS)

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.

K261892ProRib Fixation SystemCosta Surgical, Inc.K262098EnHAnce PEEK Bunion SystemNvision Biomedical TechnologiesK262963TMC Implant Fixation SystemTreace Medical Concepts, Inc.K261647Tempo Plating System; Ultra Compression Screw SystemPace SurgicalK261830FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog)Ortler Global Tibbi Gerecler Anonim SirketiK262537Versalock Sterile Plating SystemGM Dos Reis Industria e Comercio Ltda.

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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