RESPONSIVE ORTHOPEDICS LLC

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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

Orthopedic Manual Surgical Instrument (LXH) (9) Fastener, Fixation, Nondegradable, Soft Tissue (MBI) (1)

Premarket Exempt

No Yes

Clear

Spirit - 00811714032337 Catalog Number : 90-RAC-620700

Device Description : Spirit Tap 7mm

Device Class : 1

Duns Number: 002745858

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Spirit - 00811714032344 Catalog Number : 90-RAC-620800

Device Description : Spirit Tap 8mm

Device Class : 1

Duns Number: 002745858

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Spirit - 00811714032351 Catalog Number : 90-RAC-620900

Device Description : Spirit Tap 9mm

Device Class : 1

Duns Number: 002745858

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Spirit - 00811714032368 Catalog Number : 90-RAC-621000

Device Description : Spirit Tap 10mm

Device Class : 1

Duns Number: 002745858

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Spirit - 00811714032405 Catalog Number :

Device Description : Spirit Titanium Tray

Device Class : 1

Duns Number: 002745858

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : No

Device Count : 1

Hornet - 00811714032467 Catalog Number : 90-RAA-410210

Device Description : Hornet 5.5mm, 3 Sutures

Device Class : 2

Duns Number: 002745858

Premarket Exempt : No

Product Code : MBI

Prescription Use : No

Device Count : 1

Spirit Titanium - 00811714032535 Catalog Number :

Device Description : Spirit Titanium Tap 7mm

Device Class : 1

Duns Number: 002745858

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Spirit Titanium - 00811714032542 Catalog Number :

Device Description : Spirit Titanium Tap 8mm

Device Class : 1

Duns Number: 002745858

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Spirit Titanium - 00811714032559 Catalog Number :

Device Description : Spirit Titanium Tap 9mm

Device Class : 1

Duns Number: 002745858

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Spirit Titanium - 00811714032566 Catalog Number :

Device Description : Spirit Titanium Tap 10mm

Device Class : 1

Duns Number: 002745858

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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