RESPONSIVE ORTHOPEDICS LLC

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

Fastener, Fixation, Nondegradable, Soft Tissue (MBI) (6) Orthopedic Manual Surgical Instrument (LXH) (4)

Premarket Exempt

No Yes

Clear

Awl - 00811714030005 Catalog Number : 90-RAA-405000

Device Description : Awl

Device Class : 1

Duns Number: 002745858

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Hornet - 00811714030012 Catalog Number : 90-RAA-410100

Device Description : Hornet Suture Anchor 4.5mm, 2 Sutures

Device Class : 2

Duns Number: 002745858

Premarket Exempt : No

Product Code : MBI

Prescription Use : No

Device Count : 1

Hornet - 00811714030029 Catalog Number : 90-RAA-410200

Device Description : Hornet 5.5mm, 2 Sutures

Device Class : 2

Duns Number: 002745858

Premarket Exempt : No

Product Code : MBI

Prescription Use : No

Device Count : 1

Hornet - 00811714030036 Catalog Number : 90-RAA-415100

Device Description : Hornet 4.5mm Tap

Device Class : 1

Duns Number: 002745858

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Hornet - 00811714030043 Catalog Number : 90-RAA-415200

Device Description : Hornet 5.5mm Tap

Device Class : 1

Duns Number: 002745858

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Harrier - 00811714030050 Catalog Number : 90-RAA-420100

Device Description : Harrier Suture Anchor 4.5mm

Device Class : 2

Duns Number: 002745858

Premarket Exempt : No

Product Code : MBI

Prescription Use : No

Device Count : 1

Harrier - 00811714030067 Catalog Number : 90-RAA-420200

Device Description : Harrier Suture Anchor 5.5mm

Device Class : 2

Duns Number: 002745858

Premarket Exempt : No

Product Code : MBI

Prescription Use : No

Device Count : 1

Lightning - 00811714030081 Catalog Number : 90-RAA-850100

Device Description : Lightning Suture Anchor Long

Device Class : 2

Duns Number: 002745858

Premarket Exempt : No

Product Code : MBI

Prescription Use : No

Device Count : 1

Lightning - 00811714030098 Catalog Number : 90-RAA-850200

Device Description : Lightning Suture Anchor Short

Device Class : 2

Duns Number: 002745858

Premarket Exempt : No

Product Code : MBI

Prescription Use : No

Device Count : 1

Lightning - 00811714030128 Catalog Number : 90-RAA-855100

Device Description : Lightning Drill Long

Device Class : 1

Duns Number: 002745858

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

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