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) (7) Fastener, Fixation, Nondegradable, Soft Tissue (MBI) (3) Screw, Fixation, Bone (HWC) (1)

Premarket Exempt

No Yes

Clear

Lightning - 00811714030142 Catalog Number : 90-RAA-855300

Device Description : Lightning Drill Short

Device Class : 1

Duns Number: 002745858

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Lightning - 00811714030166 Catalog Number : 90-RAA-857110

Device Description : Lightning Guide Tube Crown Long

Device Class : 1

Duns Number: 002745858

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Lightning - 00811714030173 Catalog Number : 90-RAA-857120

Device Description : Lightning Guide Tube V-Mouth Long

Device Class : 1

Duns Number: 002745858

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Lightning - 00811714030203 Catalog Number : 90-RAA-857310

Device Description : Lightning Guide Tube Crown Short

Device Class : 1

Duns Number: 002745858

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Lightning - 00811714030210 Catalog Number : 90-RAA-857320

Device Description : Lightning Guide Tube V-Mouth Short

Device Class : 1

Duns Number: 002745858

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Lightning - 00811714030241 Catalog Number : 90-RAA-857511

Device Description : Lightning Probe Short

Device Class : 1

Duns Number: 002745858

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Lightning - 00811714030258 Catalog Number : 90-RAA-857512

Device Description : Lightning Probe Long

Device Class : 1

Duns Number: 002745858

Premarket Exempt : Yes

Product Code : LXH

Prescription Use : Yes

Device Count : 1

Nighthawk - 00811714030265 Catalog Number : 90-RAA-860100

Device Description : Nighthawk Suture Anchor Long

Device Class : 2

Duns Number: 002745858

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Nighthawk - 00811714030289 Catalog Number : 90-RAA-860300

Device Description : Nighthawk Suture Anchor Short

Device Class : 2

Duns Number: 002745858

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

Spirit - 00811714030654 Catalog Number :

Device Description : Spirit PEEK 07 x 23

Device Class : 2

Duns Number: 002745858

Premarket Exempt : No

Product Code : MBI, HWC

Prescription Use : No

Device Count : 1

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