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)

MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079

K-Number: K101835 · 2010-12-03

ApplicantPorex Surgical, Inc.
Decision Date2010-12-03
Product CodeHBW
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 is the device name listed in this FDA 510(k) record. The listed applicant is Porex Surgical, Inc.. It received FDA 510(k) clearance on 2010-12-03 under 510(k) number K101835. The device is classified under product code HBW. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079?

MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 is a medical device that received FDA 510(k) clearance on 2010-12-03. The listed applicant is Porex Surgical, Inc.. The 510(k) number is K101835.

When did MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 receive FDA 510(k) clearance?

MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 received FDA 510(k) clearance on 2010-12-03, under 510(k) number K101835.

Who is the listed applicant for MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079?

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

What is the FDA product code for MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079?

The FDA product code for MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 is HBW.

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 Porex Surgical, 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.

K102184MEDPOR CONTAIN CAN IMPLANTK091807MEDPOR FIXATION SYSTEMK091120MEDPOR CONTAIN IMPLANTK083621MEDPOR CUSTOMIZED SURGICAL IMPLANTK071335MEDPOR ATTRACTOR IMPLANTK052297POREX ELECTROSURGERY NEEDLE

View all 19 devices →

Related Devices (Code: HBW)

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.

K251472Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System; Inion CPS 1.5 Baby Bioabsorbable Fixation SystemInion OYK231208Stryker Resorbable Fixation SystemStryker Leibinger GmbH & Co KGK171152Stryker Universal Neuro III System AXS ScrewStrykerK001353MEMOGRAPH; OSSTAPLE - NEUROSURGICAL USES FOR CRANIOFACIAL FRACTURES AND CRANIOPLASTY FOR THE MEMOGRAPH STAPLE SYSTEMBiomedical Ent., 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.

↑