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FDA 510(k)

SILMAX PECTORAL IMPLANT

K-Number: K002633 · 2000-11-21

ApplicantPillar Surgical, Inc.
Decision Date2000-11-21
Product CodeMIC
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

SILMAX PECTORAL IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Pillar Surgical, Inc.. It received FDA 510(k) clearance on 2000-11-21 under 510(k) number K002633. The device is classified under product code MIC. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SILMAX PECTORAL IMPLANT?

SILMAX PECTORAL IMPLANT is a medical device that received FDA 510(k) clearance on 2000-11-21. The listed applicant is Pillar Surgical, Inc.. The 510(k) number is K002633.

When did SILMAX PECTORAL IMPLANT receive FDA 510(k) clearance?

SILMAX PECTORAL IMPLANT received FDA 510(k) clearance on 2000-11-21, under 510(k) number K002633.

Who is the listed applicant for SILMAX PECTORAL IMPLANT?

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

What is the FDA product code for SILMAX PECTORAL IMPLANT?

The FDA product code for SILMAX PECTORAL IMPLANT is MIC.

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 Pillar 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.

K002629SILMAX CONTOUR CARVING BLOCK IMPLANTK992239PILLAR CHIN IMPLANTK992242PILLAR NASAL, DORSAL COLUMELLA AND NASAL DORSUM IMPLANTSK992240PILLAR MALAR IMPLANT

Related Devices (Code: MIC)

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.

K021337AART PECTORALIS IMPLANTAesthetic and Reconstructive Technologies, Inc.K983043SEARE BIOMEDICAL SILICONE BLOCKSeare Biomedical Corp.K982762SEARE BIOMEDICAL PECTORALIS IMPLANTSeare Biomedical Corp.K973729POWERFLEX PEC IMPLANTHanson Medical, Inc.K961072PEC IMPLANTRand Scientific Corp.K944163SPECTRUM DISIGNS PECTORAL IMPLANTSpectrum Designs, 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.

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