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FDA 510(k)

NEUROSURGICAL HEADFRAME ACCESSORIES

K-Number: K902517 · 1990-07-03

ApplicantSims Surgical, Inc.
Decision Date1990-07-03
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

NEUROSURGICAL HEADFRAME ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Sims Surgical, Inc.. It received FDA 510(k) clearance on 1990-07-03 under 510(k) number K902517. 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 NEUROSURGICAL HEADFRAME ACCESSORIES?

NEUROSURGICAL HEADFRAME ACCESSORIES is a medical device that received FDA 510(k) clearance on 1990-07-03. The listed applicant is Sims Surgical, Inc.. The 510(k) number is K902517.

When did NEUROSURGICAL HEADFRAME ACCESSORIES receive FDA 510(k) clearance?

NEUROSURGICAL HEADFRAME ACCESSORIES received FDA 510(k) clearance on 1990-07-03, under 510(k) number K902517.

Who is the listed applicant for NEUROSURGICAL HEADFRAME ACCESSORIES?

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

What is the FDA product code for NEUROSURGICAL HEADFRAME ACCESSORIES?

The FDA product code for NEUROSURGICAL HEADFRAME ACCESSORIES is GZT.

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Other records listing Sims 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.

K902180TRACHEAL TUBE STYLETK902516NEW LENGTH SUGITA APPLIERS

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

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