Integrity Implants Inc.

Address:354 Hiatt Drive,Palm Bch Gdns,FL,33418,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, Spinal Interlaminal (KWP) (9) Thoracolumbosacral Pedicle Screw System (NKB) (9) Orthopedic Manual Surgical Instrument (LXH) (1)

Premarket Exempt

No Yes

Clear

N/A - 00081861302144 Catalog Number :

Device Class : 1

Duns Number: 080300717

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

LineSider - 00810004720091 Catalog Number : LS-RD50E030

Device Description : CoCr Rod - MIS - 5.0mm 30mm Curved

Device Class : 2

Duns Number: 080300717

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

LineSider - 00810004720107 Catalog Number : LS-RD50E035

Device Description : CoCr Rod - MIS - 5.0mm 35mm Curved

Device Class : 2

Duns Number: 080300717

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

LineSider - 00810004720114 Catalog Number : LS-RD50E040

Device Description : CoCr Rod - MIS - 5.0mm 40mm Curved

Device Class : 2

Duns Number: 080300717

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

LineSider - 00810004720121 Catalog Number : LS-RD50E045

Device Description : CoCr Rod - MIS - 5.0mm 45mm Curved

Device Class : 2

Duns Number: 080300717

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

LineSider - 00810004720138 Catalog Number : LS-RD50E050

Device Description : CoCr Rod - MIS - 5.0mm 50mm Curved

Device Class : 2

Duns Number: 080300717

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

LineSider - 00810004720145 Catalog Number : LS-RD50E055

Device Description : CoCr Rod - MIS - 5.0mm 55mm Curved

Device Class : 2

Duns Number: 080300717

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

LineSider - 00810004720152 Catalog Number : LS-RD50E060

Device Description : CoCr Rod - MIS - 5.0mm 60mm Curved

Device Class : 2

Duns Number: 080300717

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

LineSider - 00810004720169 Catalog Number : LS-RD50E065

Device Description : CoCr Rod - MIS - 5.0mm 65mm Curved

Device Class : 2

Duns Number: 080300717

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

LineSider - 00810004720176 Catalog Number : LS-RD50E070

Device Description : CoCr Rod - MIS - 5.0mm 70mm Curved

Device Class : 2

Duns Number: 080300717

Premarket Exempt : No

Product Code : KWP, NKB

Prescription Use : Yes

Device Count : 1

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