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)

PIPELINE II ACCESS SYSTEM

K-Number: K062814 · 2006-12-15

ApplicantDepuy Spine, Inc.
Decision Date2006-12-15
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PIPELINE II ACCESS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Depuy Spine, Inc.. It received FDA 510(k) clearance on 2006-12-15 under 510(k) number K062814. The device is classified under product code GZT. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PIPELINE II ACCESS SYSTEM?

PIPELINE II ACCESS SYSTEM is a medical device that received FDA 510(k) clearance on 2006-12-15. The listed applicant is Depuy Spine, Inc.. The 510(k) number is K062814.

When did PIPELINE II ACCESS SYSTEM receive FDA 510(k) clearance?

PIPELINE II ACCESS SYSTEM received FDA 510(k) clearance on 2006-12-15, under 510(k) number K062814.

Who is the listed applicant for PIPELINE II ACCESS SYSTEM?

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

What is the FDA product code for PIPELINE II ACCESS SYSTEM?

The FDA product code for PIPELINE II ACCESS SYSTEM is GZT.

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 Depuy Spine, 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.

K201831CONFIDENCE Spinal Cement SystemK111136EXPEDIUM SPINE SYSTEM, VIPER SYSTEM, VIPER 2 SYSTEMK121020VIPER SYSTEMK110353MOUNTAINEER OCT SPINAL SYSTEMK110216EXPEDIUM SYSTEM, VIPER SYSTEMK103133VEPER SYSTEM, EXPEDIUM SYSTEM

View all 67 devices →

Related Devices (Code: GZT)

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.

K252995Durashield Device KitSurGenTec, LLCK210615Thompson Brain Retractor Table Mounted (TM), Thompson Brain Retractor Skull Clamp Mounted (SCM)Thompson Surgical Instruments, Inc.K202694Vycor Medical Viewsite Brain Access System (“VBAS”) and VBAS with Alignment Clip (“VBAS AC”) (together the “VBAS Family”)Vycor Medical, Inc.K202072MindsEye Expandable PortMinnetronix Neuro, Inc.K180610Geister retractor for neuro - and spine surgeryGeister Medizin Technik GmbHK172433NICO BrainPathNico Corporation

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.

↑