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FDA 510(k)

TORQUE INSTRUMENT, MODEL 8500

K-Number: K001476 · 2000-08-04

ApplicantSpinalight, Inc.
Decision Date2000-08-04
Product CodeLXM
DecisionSubstantially Equivalent

Device Summary

TORQUE INSTRUMENT, MODEL 8500 is the device name listed in this FDA 510(k) record. The listed applicant is Spinalight, Inc.. It received FDA 510(k) clearance on 2000-08-04 under 510(k) number K001476. The device is classified under product code LXM. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TORQUE INSTRUMENT, MODEL 8500?

TORQUE INSTRUMENT, MODEL 8500 is a medical device that received FDA 510(k) clearance on 2000-08-04. The listed applicant is Spinalight, Inc.. The 510(k) number is K001476.

When did TORQUE INSTRUMENT, MODEL 8500 receive FDA 510(k) clearance?

TORQUE INSTRUMENT, MODEL 8500 received FDA 510(k) clearance on 2000-08-04, under 510(k) number K001476.

Who is the listed applicant for TORQUE INSTRUMENT, MODEL 8500?

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

What is the FDA product code for TORQUE INSTRUMENT, MODEL 8500?

The FDA product code for TORQUE INSTRUMENT, MODEL 8500 is LXM.

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Other records listing Spinalight, 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.

K172536Atlas Percussion Adjusting InstrumentK955540HAND HELD ATLAS INSTRUMENTK946258MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENTK945954MODELS 4100 AND 4300 MULTITHERAPYK933622FLEXION DISTRACTION TABLEK933621HILO TABLE

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Related Devices (Code: LXM)

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.

K234036SONIK MONARK 100Neuro Spinal Innovation, Inc.K192629SpinalyticsOptima Health Solutions International Corp.K172536Atlas Percussion Adjusting InstrumentSpinalight, Inc.K160278VSTAAR AdjusteRSpinal Acoustics, LLCK112606ACTIVATOR V-EActivator Methods International, Ltd.K082218MAX ADJUSTING INSTRUMENTManna Omni International, 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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