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FDA 510(k)

SEMI-TUBULAR PLATE

K-Number: K931688 · 1994-04-25

ApplicantOnyx Medical Corp.
Decision Date1994-04-25
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

SEMI-TUBULAR 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 1994-04-25 under 510(k) number K931688. 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 SEMI-TUBULAR PLATE?

SEMI-TUBULAR PLATE is a medical device that received FDA 510(k) clearance on 1994-04-25. The listed applicant is Onyx Medical Corp.. The 510(k) number is K931688.

When did SEMI-TUBULAR PLATE receive FDA 510(k) clearance?

SEMI-TUBULAR PLATE received FDA 510(k) clearance on 1994-04-25, under 510(k) number K931688.

Who is the listed applicant for SEMI-TUBULAR 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 SEMI-TUBULAR PLATE?

The FDA product code for SEMI-TUBULAR 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 SCREWK931684EPIPHYSIS PLATE

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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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