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)

MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI

K-Number: K861822 · 1986-07-11

ApplicantValley Forge Scientific Corp.
Decision Date1986-07-11
Product CodeGWO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI is the device name listed in this FDA 510(k) record. The listed applicant is Valley Forge Scientific Corp.. It received FDA 510(k) clearance on 1986-07-11 under 510(k) number K861822. The device is classified under product code GWO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI?

MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI is a medical device that received FDA 510(k) clearance on 1986-07-11. The listed applicant is Valley Forge Scientific Corp.. The 510(k) number is K861822.

When did MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI receive FDA 510(k) clearance?

MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI received FDA 510(k) clearance on 1986-07-11, under 510(k) number K861822.

Who is the listed applicant for MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI?

The FDA 510(k) record lists Valley Forge Scientific Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI?

The FDA product code for MALIS SURGICAL MESH FOR SKULL /SPINAL COLUMN REPAI is GWO.

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 Valley Forge Scientific 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.

K050364MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEMK042604VALLY FORGE SCIENTIFIC MALIS BIPOLAR DISPOSABLE FINGER OPERATED ELECTROSURGICAL INSTRUMENTSK032601STRYKER INTERVENTIONAL PAIN RF GENERATORK033499MALIS IRRIGATION MODULE 1000K982229BI-DENTK973554VALLEY FORGE BIPOLAR BALL TIP ELECTRODE

View all 27 devices →

Related Devices (Code: GWO)

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.

K262874CraniUS PlateCraniUS, LLCK261058CraniUS PlateCraniUS, LLCK250297TECHFIT Patient-Specific Cranial SystemTechfit Digital Surgery, Inc.K250334Fusion Craniofacial Implant; Fusion Skull ImplantKelyniam Global, Inc.K231834VSP PEEK Cranial Implant3D Systems, Inc.K212391MCI-Neuro Fixation SystemMci Medical Concept Innovation, 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.

↑