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FDA 510(k)

LEAPLAZA FRAME

K-Number: K922238 · 1992-12-23

ApplicantSpintech, Inc.
Decision Date1992-12-23
Product CodeKWP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

LEAPLAZA FRAME is the device name listed in this FDA 510(k) record. The listed applicant is Spintech, Inc.. It received FDA 510(k) clearance on 1992-12-23 under 510(k) number K922238. The device is classified under product code KWP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEAPLAZA FRAME?

LEAPLAZA FRAME is a medical device that received FDA 510(k) clearance on 1992-12-23. The listed applicant is Spintech, Inc.. The 510(k) number is K922238.

When did LEAPLAZA FRAME receive FDA 510(k) clearance?

LEAPLAZA FRAME received FDA 510(k) clearance on 1992-12-23, under 510(k) number K922238.

Who is the listed applicant for LEAPLAZA FRAME?

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

What is the FDA product code for LEAPLAZA FRAME?

The FDA product code for LEAPLAZA FRAME is KWP.

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Other records listing Spintech, 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.

K223079StageK210843STAGEK173224SPIN-SWIK023722SAFETYWAND DISPOSABLE HANDPIECEK010692THE WAND PLUS COMPUTER CONTROLLED ANESTHETIC DELIVERY SYSTEMK992404THE WAND

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Related Devices (Code: KWP)

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.

K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLCK132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLCK131427LOTUSSpinal Elements, Inc.K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARLK131156LANX SPINAL FIXATION SYSTEMLanx, Inc.

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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