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)

LESSER METATARSAL PHALANG. JOINT PROSTH

K-Number: K820813 · 1982-05-21

ApplicantSutter Biomedical, Inc.
Decision Date1982-05-21
Product CodeKWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LESSER METATARSAL PHALANG. JOINT PROSTH is the device name listed in this FDA 510(k) record. The listed applicant is Sutter Biomedical, Inc.. It received FDA 510(k) clearance on 1982-05-21 under 510(k) number K820813. The device is classified under product code KWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LESSER METATARSAL PHALANG. JOINT PROSTH?

LESSER METATARSAL PHALANG. JOINT PROSTH is a medical device that received FDA 510(k) clearance on 1982-05-21. The listed applicant is Sutter Biomedical, Inc.. The 510(k) number is K820813.

When did LESSER METATARSAL PHALANG. JOINT PROSTH receive FDA 510(k) clearance?

LESSER METATARSAL PHALANG. JOINT PROSTH received FDA 510(k) clearance on 1982-05-21, under 510(k) number K820813.

Who is the listed applicant for LESSER METATARSAL PHALANG. JOINT PROSTH?

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

What is the FDA product code for LESSER METATARSAL PHALANG. JOINT PROSTH?

The FDA product code for LESSER METATARSAL PHALANG. JOINT PROSTH is KWH.

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 Sutter Biomedical, 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.

K875249SUTTER PHALANGEAL CAPK870200SUTTER FINGER JOINT PROSTHESISK861983SUTTER LESSER METATARSAL CAPK850274SUTTER CPM 9000 -NONMEASURING EXERCISE EQUIPMENTK830974SUTTER CPM 5000K830649SUTTER CPM 2000

View all 11 devices →

Related Devices (Code: KWH)

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.

K191966NewPrim SystemBrm ExtremitiesK190136Fusion Silastic SystemFusion Orthopedics, LLCK173491RTS Lesser MTP Implant SystemIn2bones USA, LLCK153609RTS Flexible 1 MPJ Implant w/GrommetsIn2bones USA, LLCK102601ORTHOFLEX RODOrtho-Pro, LLCK023531LESSER METATARSAL PHALANGEAL JOINT IMPLANTNexa Orthopedics, Inc.

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.

↑