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FDA 510(k)

CRANK FRAME RETRACTOR

K-Number: K882071 · 1988-06-10

ApplicantKarlin Technology, Inc.
Decision Date1988-06-10
Product CodeGZT
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

CRANK FRAME RETRACTOR is the device name listed in this FDA 510(k) record. The listed applicant is Karlin Technology, Inc.. It received FDA 510(k) clearance on 1988-06-10 under 510(k) number K882071. 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 CRANK FRAME RETRACTOR?

CRANK FRAME RETRACTOR is a medical device that received FDA 510(k) clearance on 1988-06-10. The listed applicant is Karlin Technology, Inc.. The 510(k) number is K882071.

When did CRANK FRAME RETRACTOR receive FDA 510(k) clearance?

CRANK FRAME RETRACTOR received FDA 510(k) clearance on 1988-06-10, under 510(k) number K882071.

Who is the listed applicant for CRANK FRAME RETRACTOR?

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

What is the FDA product code for CRANK FRAME RETRACTOR?

The FDA product code for CRANK FRAME RETRACTOR is GZT.

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Other records listing Karlin Technology, 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.

K903969SUCTION RETRACTOR(TOWER ATTACH.)FOR CRANK FRAM RETK893201BONE PLATEK893203BONE SCREWK882525SPINAL MICROKNIFEK882519X-RAY MARKERK882073SPINAL NEEDLE

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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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