ORTHOPEDIATRICS CORP.

ORTHOPEDIATRICS CORP.

Address:2850 Frontier Dr,Warsaw,IN,46582,US

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Filters

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

Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component (KTT) (10)

Premarket Exempt

No Yes

Clear

Drive Rail - 00817867020016 Catalog Number : 20-1201

Device Description : Arch Rotational Mount

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Drive Rail - 00817867020023 Catalog Number : 20-1202

Device Description : Rail Rotational Mount

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Drive Rail - 00817867020030 Catalog Number : 20-1203

Device Description : Clamp Rotational Mount

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Drive Rail - 00817867020047 Catalog Number : 20-1204

Device Description : Rail Hinge Mount/Rail Stop

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Drive Rail - 00817867020054 Catalog Number : 20-1209

Device Description : Arch, 9 cm

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Drive Rail - 00817867020061 Catalog Number : 20-1213

Device Description : Arch, 13 cm

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Drive Rail - 00817867020078 Catalog Number : 20-1220

Device Description : Arch, 20 cm

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Drive Rail - 00817867020085 Catalog Number : 20-1227

Device Description : Arch, 27 cm

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Drive Rail - 00817867020092 Catalog Number : 20-1234

Device Description : Arch, 34 cm

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

Drive Rail - 00817867020108 Catalog Number : 20-1241

Device Description : Arch, 41 cm

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : KTT

Prescription Use : Yes

Device Count : 1

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