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)

SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL

K-Number: K831884 · 1983-09-20

ApplicantRichards Manufacturer Co.
Decision Date1983-09-20
Product CodeJDI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL is the device name listed in this FDA 510(k) record. The listed applicant is Richards Manufacturer Co.. It received FDA 510(k) clearance on 1983-09-20 under 510(k) number K831884. 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 SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL?

SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL is a medical device that received FDA 510(k) clearance on 1983-09-20. The listed applicant is Richards Manufacturer Co.. The 510(k) number is K831884.

When did SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL receive FDA 510(k) clearance?

SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL received FDA 510(k) clearance on 1983-09-20, under 510(k) number K831884.

Who is the listed applicant for SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL?

The FDA 510(k) record lists Richards Manufacturer Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL?

The FDA product code for SPECTRON EXTRA-SMALL, STRAIGHT FEMORAL 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 Richards Manufacturer Co. 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.

K831999FEMORAL CANAL SUCTION TAMPONK832000THIGH HOLDERK831656ARTHROSCOPY KNIVES/PROBES/BENDING TOOL

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.

↑