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FDA 510(k)

VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM

K-Number: K964402 · 1997-01-23

ApplicantV. Mueller Neuro/Spine
Decision Date1997-01-23
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is V. Mueller Neuro/Spine. It received FDA 510(k) clearance on 1997-01-23 under 510(k) number K964402. 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 VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM?

VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM is a medical device that received FDA 510(k) clearance on 1997-01-23. The listed applicant is V. Mueller Neuro/Spine. The 510(k) number is K964402.

When did VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM receive FDA 510(k) clearance?

VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM received FDA 510(k) clearance on 1997-01-23, under 510(k) number K964402.

Who is the listed applicant for VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM?

The FDA 510(k) record lists V. Mueller Neuro/Spine as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM?

The FDA product code for VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM is GZT.

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Other records listing V. Mueller Neuro/Spine 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.

K002276PSI SKULL CLAMPK993019PACIFIC SURGICAL PATTIESK991959PSI TITANIUM ANEURYSM CLIPK991002PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIPK972750TAKA ANEURYSM CLIPK942601PSI FLEXIBLE ARM

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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.

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