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)

ARTHROPLASTY MALLET

K-Number: K872209 · 1987-06-23

ApplicantNew England Surgical Instrument Corp.
Decision Date1987-06-23
Product CodeHXL
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

ARTHROPLASTY MALLET is the device name listed in this FDA 510(k) record. The listed applicant is New England Surgical Instrument Corp.. It received FDA 510(k) clearance on 1987-06-23 under 510(k) number K872209. The device is classified under product code HXL. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHROPLASTY MALLET?

ARTHROPLASTY MALLET is a medical device that received FDA 510(k) clearance on 1987-06-23. The listed applicant is New England Surgical Instrument Corp.. The 510(k) number is K872209.

When did ARTHROPLASTY MALLET receive FDA 510(k) clearance?

ARTHROPLASTY MALLET received FDA 510(k) clearance on 1987-06-23, under 510(k) number K872209.

Who is the listed applicant for ARTHROPLASTY MALLET?

The FDA 510(k) record lists New England Surgical Instrument Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARTHROPLASTY MALLET?

The FDA product code for ARTHROPLASTY MALLET is HXL.

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 New England Surgical Instrument Corp. 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.

K895337ELECTROSURGICAL COAGULATION SUCTION TUBEK895331ELECTROSURGICAL ELECTRODEK883963RANEY AND LEROY-RANEY SCALP CLIPK883396HANDSWITCHING MONOPOLAR PENCILK880863BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200K880859SURGICAL BURS

View all 18 devices →

Related Devices (Code: HXL)

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.

K882349MALLET, SURGICALTreace Medical, Inc.K871195MALLET, BONE SURGERY, STAINLESS STEEL, 2LB.Military Engineering, 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.

↑