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FDA 510(k)

MODIFIED MEMORY RETRACTOR ARM

K-Number: K895537 · 1989-09-22

ApplicantMedical Equipment Development Co., Inc.
Decision Date1989-09-22
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

MODIFIED MEMORY RETRACTOR ARM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Equipment Development Co., Inc.. It received FDA 510(k) clearance on 1989-09-22 under 510(k) number K895537. 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 MODIFIED MEMORY RETRACTOR ARM?

MODIFIED MEMORY RETRACTOR ARM is a medical device that received FDA 510(k) clearance on 1989-09-22. The listed applicant is Medical Equipment Development Co., Inc.. The 510(k) number is K895537.

When did MODIFIED MEMORY RETRACTOR ARM receive FDA 510(k) clearance?

MODIFIED MEMORY RETRACTOR ARM received FDA 510(k) clearance on 1989-09-22, under 510(k) number K895537.

Who is the listed applicant for MODIFIED MEMORY RETRACTOR ARM?

The FDA 510(k) record lists Medical Equipment Development Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MODIFIED MEMORY RETRACTOR ARM?

The FDA product code for MODIFIED MEMORY RETRACTOR ARM is GZT.

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Other records listing Medical Equipment Development Co., 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.

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Related Devices (Code: GZT)

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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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