ORTHO KINEMATICS, INC.

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Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Image Processing, Radiological (LLZ) (5) System, X-Ray, Film Marking, Radiographic (JAC) (1) Table, Mechanical (INW) (1)

Premarket Exempt

No Yes

Clear

VMA - 00868579000209 Catalog Number :

Device Class : 2

Duns Number: 932053221

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

VMA DataLink Software - 00868579000216 Catalog Number :

Device Class : 2

Duns Number: 932053221

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

VMA DataLink Software - 00868579000223 Catalog Number :

Device Description : VMA DataLink Software (SW4) available to customers on Ortho Kinematics secure site

Device Class : 2

Duns Number: 932053221

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

VMA Image Acquisition Software - 00868579000230 Catalog Number :

Device Description : VMA Image Acquisition Software (SW1) installed on VMA (Motion Normalizer Console)

Device Class : 2

Duns Number: 932053221

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

VMA Motion Normalizer - 00868579000247 Catalog Number :

Device Description : VMA Motion Normalizer (Console, Table, and Upright assemblies)

Device Class : 2

Duns Number: 932053221

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

Profile-ESP Bolster - 00868579000261 Catalog Number :

Device Description : The Profile-ESP Bolster device is an optional patient positioning accessory for The Profile-ESP Bolster device is an optional patient positioning accessory for use within the Profile-ESP workflow of the VMA System. The patient's pelvis is secured while performing the indicated spinal flexion and extension bending.The dimensions are approximately 40-47” wide (adjustable width), 24” deep, 42-58” tall (adjustable height). Weight is approximately 98 lbs. (44 kg).

Device Class : 1

Duns Number: 932053221

Premarket Exempt : Yes

Product Code : INW

Prescription Use : Yes

Device Count : 1

Profile-ESP Radiographic marker - 00868579000278 Catalog Number :

Device Description : The Profile-ESP Radiographic Marker is an accessory for use within the Profile-E The Profile-ESP Radiographic Marker is an accessory for use within the Profile-ESP workflow of the VMA System. It can facilitate the conversion of measurement data by the Profile-ESP software to mm units, and facilitates stitching of spinal x-rays as part of the Image Processing service. The marker is placed around the neck of the patient by the medical imaging professional during x-ray imaging. It is shipped by Company personnel to the customer site and includes a user manual in the device package. No additional training or installation is required.Length – approximately 36” / Weight – approximately 5 oz.

Device Class : 1

Duns Number: 932053221

Premarket Exempt : Yes

Product Code : JAC

Prescription Use : Yes

Device Count : 1

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