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 SR MTP TOE IMPLANT

K-Number: K073635 · 2008-03-19

ApplicantSmall Bone Innovations, Inc.
Decision Date2008-03-19
Product CodeKWD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SBI SR MTP TOE IMPLANT 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 2008-03-19 under 510(k) number K073635. The device is classified under product code KWD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SBI SR MTP TOE IMPLANT?

SBI SR MTP TOE IMPLANT is a medical device that received FDA 510(k) clearance on 2008-03-19. The listed applicant is Small Bone Innovations, Inc.. The 510(k) number is K073635.

When did SBI SR MTP TOE IMPLANT receive FDA 510(k) clearance?

SBI SR MTP TOE IMPLANT received FDA 510(k) clearance on 2008-03-19, under 510(k) number K073635.

Who is the listed applicant for SBI SR MTP TOE IMPLANT?

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 SR MTP TOE IMPLANT?

The FDA product code for SBI SR MTP TOE IMPLANT is KWD.

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 SYSTEMK071541SBI TWISTOFIX

View all 20 devices →

Related Devices (Code: KWD)

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.

K250074HYALEX® MTP Hemiarthroplasty ImplantHyalex Orthopaedics, Inc.K240268Accu-Joint Hemi ImplantAccufix Surgical, Inc.K221220Montross Extremity Medical Hemi Implant SystemMontross Extremity MedicalK222964BioPoly Lesser Toe Hemiarthroplasty ImplantBioPoly, LLCK201393restor3d MTP ImplantRestor3D, Inc.K203634BioPoly Great Toe Hemiarthroplasty ImplantBioPoly, LLC

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.

↑