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FDA 510(k)

EPIPHYSIS PLATE

K-Number: K931684 · 1994-05-04

ApplicantOnyx Medical Corp.
Decision Date1994-05-04
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

EPIPHYSIS PLATE is the device name listed in this FDA 510(k) record. The listed applicant is Onyx Medical Corp.. It received FDA 510(k) clearance on 1994-05-04 under 510(k) number K931684. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the EPIPHYSIS PLATE?

EPIPHYSIS PLATE is a medical device that received FDA 510(k) clearance on 1994-05-04. The listed applicant is Onyx Medical Corp.. The 510(k) number is K931684.

When did EPIPHYSIS PLATE receive FDA 510(k) clearance?

EPIPHYSIS PLATE received FDA 510(k) clearance on 1994-05-04, under 510(k) number K931684.

Who is the listed applicant for EPIPHYSIS PLATE?

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

What is the FDA product code for EPIPHYSIS PLATE?

The FDA product code for EPIPHYSIS PLATE is HRS.

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Other records listing Onyx Medical Corp. 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.

K942022FACE-IT SHIELDK931690SPOON PLATEK934614MINI FRAGMENT PLATEK931692T-PLATEK931680CANNULATED CANCELLOUS SCREWK934615CANCELLOUS BONE SCREW

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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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