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)

POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185

K-Number: K032607 · 2003-11-10

ApplicantLinvatec Corp.
Decision Date2003-11-10
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Corp.. It received FDA 510(k) clearance on 2003-11-10 under 510(k) number K032607. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185?

POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 is a medical device that received FDA 510(k) clearance on 2003-11-10. The listed applicant is Linvatec Corp.. The 510(k) number is K032607.

When did POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 receive FDA 510(k) clearance?

POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 received FDA 510(k) clearance on 2003-11-10, under 510(k) number K032607.

Who is the listed applicant for POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185?

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

What is the FDA product code for POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185?

The FDA product code for POWERPRO PNEUMATIC SYSTEM, MODELS PRO6150, PRO6175, PRO6185 is DZI.

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 Linvatec 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.

K092998CONMED LINVATEC INTERCEPT IMPLANTK091549CONMED LINVATEC SOFT TISSUE TO BONE SYSTEMK090835CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CRK090186CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURESK083281EL LIGHTWAVE SUCTION ABLATOR, MODEL EL-2000-S, LIGHTWAVE SUCTION ABLATOR, MODEL IA-2000-S, LIGHTWAVE ABLATOR, MODEL IA-K060198MICROPOWER HAND PIECE : MEDIUM SPEED DRILL, SAGGITAL SAW, RECIPROCATING SAW, AND OSCILLATING SAW

View all 93 devices →

Related Devices (Code: DZI)

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.

K253655Angled Screwdriver MED (M-SD090)W&H Dentalwerk Bürmoos GmbHK253776Implantmed Plus II & Piezomed Plus II ModuleW&H Dentalwerk Buermoos GmbHK254163VarioSurg 4Nakanishi, Inc.K242432MT-BoneMectron S.P.A.K240340Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd.K231087Guided Surgery KitImplant Direct Sybron Manufacturing, LLC

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.

↑