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)

PROXIMAL INTERPHALANGEAL JOINT IMPLANT

K-Number: K802342 · 1981-10-14

ApplicantSutter Biomedical, Inc.
Decision Date1981-10-14
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PROXIMAL INTERPHALANGEAL JOINT IMPLANT 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 1981-10-14 under 510(k) number K802342. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROXIMAL INTERPHALANGEAL JOINT IMPLANT?

PROXIMAL INTERPHALANGEAL JOINT IMPLANT is a medical device that received FDA 510(k) clearance on 1981-10-14. The listed applicant is Sutter Biomedical, Inc.. The 510(k) number is K802342.

When did PROXIMAL INTERPHALANGEAL JOINT IMPLANT receive FDA 510(k) clearance?

PROXIMAL INTERPHALANGEAL JOINT IMPLANT received FDA 510(k) clearance on 1981-10-14, under 510(k) number K802342.

Who is the listed applicant for PROXIMAL INTERPHALANGEAL JOINT IMPLANT?

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 PROXIMAL INTERPHALANGEAL JOINT IMPLANT?

The FDA product code for PROXIMAL INTERPHALANGEAL JOINT IMPLANT is JDI.

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: JDI)

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.

K253515Zimmer Biomet OSS™ Orthopedic Salvage System OsseoTi® Sleeves and AugmentsBiomet Orthopedics, Inc.K253434OSSTM Orthopedic Salvage SystemBiomet, Inc.K243571Trabecular Metal Acetabular Revision System, Acetabular Liners and Constrained LinersZimmer BiometK240783Anthology Hip Stems; CPCS Hip Stems; Femoral Heads; R3 Acetabular Liners; Spectron Hip Stems; Synergy Hip StemsSmith & Nephew, Inc.K241716Global Modular Replacement System, Modular Replacement System, Modular Rotating Hinge Knee ComponentHowmedica Osteonics Corp., Dba Stryker OrthopaedicsK240418Stryker Orthopaedics Hip Systems Labeling UpdateHowmedica Osteonics Corp., Dba Stryker Orthopaedics

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.

↑