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FDA 510(k)

RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS

K-Number: K061955 · 2006-08-04

ApplicantCreative Medical Designs, Inc.
Decision Date2006-08-04
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS 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 2006-08-04 under 510(k) number K061955. 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 RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS?

RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS is a medical device that received FDA 510(k) clearance on 2006-08-04. The listed applicant is Creative Medical Designs, Inc.. The 510(k) number is K061955.

When did RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS receive FDA 510(k) clearance?

RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS received FDA 510(k) clearance on 2006-08-04, under 510(k) number K061955.

Who is the listed applicant for RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS?

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 LOW PROFILE LOCKING PLATE AND INSTRUMENTS?

The FDA product code for RAYHACK LOW PROFILE LOCKING PLATE AND INSTRUMENTS is HRS.

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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.

K952766RAYHACK OSTEOTOMY SYSTEM (MODIFICATION)

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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