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FDA 510(k)

RAYHACK OSTEOTOMY SYSTEM (MODIFICATION)

K-Number: K952766 · 1995-12-13

ApplicantCreative Medical Designs, Inc.
Decision Date1995-12-13
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

RAYHACK OSTEOTOMY SYSTEM (MODIFICATION) is the device name listed in this FDA 510(k) record. The listed applicant is Creative Medical Designs, Inc.. It received FDA 510(k) clearance on 1995-12-13 under 510(k) number K952766. 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 RAYHACK OSTEOTOMY SYSTEM (MODIFICATION)?

RAYHACK OSTEOTOMY SYSTEM (MODIFICATION) is a medical device that received FDA 510(k) clearance on 1995-12-13. The listed applicant is Creative Medical Designs, Inc.. The 510(k) number is K952766.

When did RAYHACK OSTEOTOMY SYSTEM (MODIFICATION) receive FDA 510(k) clearance?

RAYHACK OSTEOTOMY SYSTEM (MODIFICATION) received FDA 510(k) clearance on 1995-12-13, under 510(k) number K952766.

Who is the listed applicant for RAYHACK OSTEOTOMY SYSTEM (MODIFICATION)?

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

What is the FDA product code for RAYHACK OSTEOTOMY SYSTEM (MODIFICATION)?

The FDA product code for RAYHACK OSTEOTOMY SYSTEM (MODIFICATION) is HRS.

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 Creative Medical Designs, 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.

K061955RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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