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) (10) APPLIANCE, FIXATION, SPINAL INTERLAMINAL (KWP) (3)

Premarket Exempt

No Yes

Clear

Response 5.5/6.0 Spine System - 00841132184707 Catalog Number : 00-1300-3171

Device Description : 5.5/6.0 Ribbed Pedicle Hook, 8.0mm

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

Response 5.5/6.0 Spine System - 00841132184714 Catalog Number : 00-1300-3172

Device Description : 5.5/6.0 Ribbed Pedicle Hook, 9.5mm

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

Response 5.5/6.0 Spine System - 00841132184721 Catalog Number : 00-1300-3173

Device Description : 5.5/6.0 Ribbed Pedicle Hook, 11.0mm

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : NKB, KWP

Prescription Use : Yes

Device Count : 1

Response 5.5/6.0 - 00841132191033 Catalog Number : 00-1750-3000

Device Description : 5.5/6.0 closed stopper

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Response 5.5/6.0 - 00841132191040 Catalog Number : 00-1750-3121

Device Description : 5.5/6.0 closed lateral 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 - 00841132191057 Catalog Number : 00-1750-3141

Device Description : 5.5/6.0 closed lateral connector, 40mm

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Response 5.5/6.0 - 00841132191064 Catalog Number : 00-1750-3161

Device Description : 5.5/6.0 closed lateral connector, 60mm

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Response 5.5/6.0 - 00841132191071 Catalog Number : 00-1750-3240

Device Description : 5.5/6.0 double open lateral connector, 40mm

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Response 5.5/6.0 - 00841132191088 Catalog Number : 00-1750-3260

Device Description : 5.5/6.0 double open lateral connector, 60mm

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

Response 5.5/6.0 - 00841132191095 Catalog Number : 00-1750-3280

Device Description : 5.5/6.0 double open lateral connector, 80mm

Device Class : 2

Duns Number: 796416191

Premarket Exempt : No

Product Code : NKB

Prescription Use : Yes

Device Count : 1

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