Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SBI RHEAD PLATING SYSTEM

K-Number: K071549 · 2007-08-07

ApplicantSmall Bone Innovations, Inc.
Decision Date2007-08-07
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SBI RHEAD PLATING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Small Bone Innovations, Inc.. It received FDA 510(k) clearance on 2007-08-07 under 510(k) number K071549. 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 SBI RHEAD PLATING SYSTEM?

SBI RHEAD PLATING SYSTEM is a medical device that received FDA 510(k) clearance on 2007-08-07. The listed applicant is Small Bone Innovations, Inc.. The 510(k) number is K071549.

When did SBI RHEAD PLATING SYSTEM receive FDA 510(k) clearance?

SBI RHEAD PLATING SYSTEM received FDA 510(k) clearance on 2007-08-07, under 510(k) number K071549.

Who is the listed applicant for SBI RHEAD PLATING SYSTEM?

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

What is the FDA product code for SBI RHEAD PLATING SYSTEM?

The FDA product code for SBI RHEAD PLATING SYSTEM 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Small Bone Innovations, 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.

K130147ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL (A3 INTERLOCKING NAIL)K112982ANATOMIC ANKLE ARTHRODESIS INTERLOCKING NAIL(A3 INTERLOCKING NAIL )K102180RHEAD RADIAL HEAD EXTENDED STEMSK092754SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061K093550MINI RAIL EXTERNAL FIXATOR SYSTEMK073635SBI SR MTP TOE IMPLANT

View all 20 devices →

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.

↑