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

Thoracolumbosacral pedicle screw system (NKB) (5)

Premarket Exempt

No Yes

Clear

Response 5.5/6.0 - 00841132191101 Catalog Number : 00-1750-3610

Device Description : 5.5/6.0 Open/ Open wedding band connector, 10mm

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Response 5.5/6.0 - 00841132191118 Catalog Number : 00-1750-3615

Device Description : 5.5/6.0 Open/ Open wedding band connector, 15mm

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Response 5.5/6.0 - 00841132191125 Catalog Number : 00-1750-3620

Device Description : 5.5/6.0 Open/ Open wedding band connector, 20mm

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Response 5.5/6.0 - 00841132191132 Catalog Number : 00-1750-3601

Device Description : 5.5/6.0 Open/ Closed wedding band

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Response 5.5/6.0 - 00841132191149 Catalog Number : 00-1750-3700

Device Description : 5.5/6.0 Open/ Open domino connector

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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