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FDA 510(k)

UNIVERSAL BONE PLATE III SYSTEM (UBP III)

K-Number: K020611 · 2002-03-27

ApplicantSpinal Concepts, Inc.
Decision Date2002-03-27
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

UNIVERSAL BONE PLATE III SYSTEM (UBP III) is the device name listed in this FDA 510(k) record. The listed applicant is Spinal Concepts, Inc.. It received FDA 510(k) clearance on 2002-03-27 under 510(k) number K020611. 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 UNIVERSAL BONE PLATE III SYSTEM (UBP III)?

UNIVERSAL BONE PLATE III SYSTEM (UBP III) is a medical device that received FDA 510(k) clearance on 2002-03-27. The listed applicant is Spinal Concepts, Inc.. The 510(k) number is K020611.

When did UNIVERSAL BONE PLATE III SYSTEM (UBP III) receive FDA 510(k) clearance?

UNIVERSAL BONE PLATE III SYSTEM (UBP III) received FDA 510(k) clearance on 2002-03-27, under 510(k) number K020611.

Who is the listed applicant for UNIVERSAL BONE PLATE III SYSTEM (UBP III)?

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

What is the FDA product code for UNIVERSAL BONE PLATE III SYSTEM (UBP III)?

The FDA product code for UNIVERSAL BONE PLATE III SYSTEM (UBP III) is HRS.

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Other records listing Spinal Concepts, 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.

K051000FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICEK050706HARMONY PORT SYSTEM, MODEL 1907 SERIESK040096SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEMK033663SPINAL CONCEPTS INC. CODAK033517SPINAL CONCEPTS INC. CADENCE AND TRAXISK031855SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM

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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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