PONTIS ORTHOPAEDICS, LLC

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- Catalog Number : 400-3011

Device Description : PONTiS Flexor Tendon Repair Implant kit with Multifilament Stainless Steel Sutur PONTiS Flexor Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp.Each Kit contains:1x size #3-0 MFSS suture with 2 curved needles (white wrap)1x size #3-0 MFSS suture with 2 curved needles (black wrap)1x SS Crimp CollarSupplied pouched, sterilized with EO.

Device Class : 2

Duns Number: 047775061

Premarket Exempt : No

Product Code : MBI, GAQ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 400-3014

Device Description : PONTiS Flexor Tendon Repair Dilating Catheter, Funnel & Threader KitEach Kit con PONTiS Flexor Tendon Repair Dilating Catheter, Funnel & Threader KitEach Kit contains:1x Dilating catheter for tendon transfer and pulley dilation1x Funnel for tendon transfer1x SS threader for threading sutures through the catheter & funnelSupplied pouched, sterilized with EO.

Device Class : 2

Duns Number: 047775061

Premarket Exempt : No

Product Code : GAQ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 400-3031

Device Description : PONTiS 3mm Anchor with Anchor Driver for Flexor Tendon Repair Each Kit contains: PONTiS 3mm Anchor with Anchor Driver for Flexor Tendon Repair Each Kit contains:1x 3mm Anchor with Driver handleAnchor has size #3-0 multifilament SS sutureEach end of SS suture has pre-attached straight needles.Supplied pouched, sterilized with EO.

Device Class : 2

Duns Number: 047775061

Premarket Exempt : No

Product Code : GAQ, MBI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 401-3006

Device Description : PONTiS Crimp Collar for Flexor Tendon Repair Each Unit contains:1x SS Crimp Coll PONTiS Crimp Collar for Flexor Tendon Repair Each Unit contains:1x SS Crimp Collar for use with PONTiS size #3-0 multifilament SS sutures.Supplied pouched, sterilized with EO.

Device Class : 2

Duns Number: 047775061

Premarket Exempt : No

Product Code : GAQ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 400-3015

Device Description : PONTiS Pre-drill Refill Pack for Flexor Tendon Repair Each Kit contains:1x Pre-d PONTiS Pre-drill Refill Pack for Flexor Tendon Repair Each Kit contains:1x Pre-drill, size 0.063" diameter x 4" length1x Pre-drill, size 0.078" diameter x 4" length1x Pre-drill, size 0.094" diameter x 4" length> For replacement of components of the PONTiS Crimp Instrument Sets (p/n 400-5563 or 400-5565)Supplied Non-Sterile.

Device Class : 2

Duns Number: 047775061

Premarket Exempt : No

Product Code : MBI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 600-4001

Device Description : PONTiS Achilles Tendon Repair Implant kit with Multifilament Stainless Steel Sut PONTiS Achilles Tendon Repair Implant kit with Multifilament Stainless Steel Sutures and SS Crimp.Each Kit contains:1x size #3 MFSS suture with 2 curved needles (white wrap)1x size #3 MFSS suture with 2 curved needles (black wrap)1x SS Crimp Collar for #3 SS suturesSupplied pouched, sterilized with EO.

Device Class : 2

Duns Number: 047775061

Premarket Exempt : No

Product Code : GAQ

Prescription Use : Yes

Device Count : 1

- Catalog Number : 400-3020

Device Description : PONTiS Dual Suture-Crimp Implant kit with Multifilament Stainless Steel Sutures PONTiS Dual Suture-Crimp Implant kit with Multifilament Stainless Steel Sutures and SS CrimpEach Kit contains:1x Dual #3-0 MFSS sutures with 2 straight needles1x SS Crimp collarSupplied pouched, sterilized with EO

Device Class : 2

Duns Number: 047775061

Premarket Exempt : No

Product Code : GAQ, MBI

Prescription Use : Yes

Device Count : 1