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Found 2 results

510(k) Data Aggregation

K Number

Device Name

TORQUE INSTRUMENT, MODEL 8500

Manufacturer

SPINALIGHT, INC.

Date Cleared

2000-08-04

(85 days)

Product Code

Regulation Number

N/A

Type

Panel

Physical Medicine

Reference & Predicate Devices

N/A

Predicate For

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

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K Number

Device Name

HAND HELD ATLAS INSTRUMENT

Manufacturer

SPINALIGHT, INC.

Date Cleared

1996-03-04

(90 days)

Product Code

Regulation Number

N/A

Type

Panel

Physical Medicine

Reference & Predicate Devices

N/A

Predicate For

N/A

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

Device Description

AI/ML Overview

Ask a Question

Ask a specific question about this device

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