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FDA 510(k)

COD COMPRESSION OSTEOTOMY DEVICE

K-Number: K002184 · 2000-11-24

ApplicantWalter Abendschein, M.D.
Decision Date2000-11-24
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COD COMPRESSION OSTEOTOMY DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Walter Abendschein, M.D.. It received FDA 510(k) clearance on 2000-11-24 under 510(k) number K002184. 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 COD COMPRESSION OSTEOTOMY DEVICE?

COD COMPRESSION OSTEOTOMY DEVICE is a medical device that received FDA 510(k) clearance on 2000-11-24. The listed applicant is Walter Abendschein, M.D.. The 510(k) number is K002184.

When did COD COMPRESSION OSTEOTOMY DEVICE receive FDA 510(k) clearance?

COD COMPRESSION OSTEOTOMY DEVICE received FDA 510(k) clearance on 2000-11-24, under 510(k) number K002184.

Who is the listed applicant for COD COMPRESSION OSTEOTOMY DEVICE?

The FDA 510(k) record lists Walter Abendschein, M.D. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COD COMPRESSION OSTEOTOMY DEVICE?

The FDA product code for COD COMPRESSION OSTEOTOMY DEVICE is HRS.

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Other records listing Walter Abendschein, M.D. 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.

K011603VHS PEDIATRIC HIP SCREW SYSTEMK000827UNICOMPARTMENTAL PATELLOFEMORAL PROSTHESIS (UPP) CEMENTEDK991806VHS SUPRACONDYLAR PLATE SYSTEMK964880VARI-ANGLE HIP SCREW (VHS) SYSTEM

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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