pontisorthopaedic.com
pontisorthopaedics.comMULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS
PONTIS ORTHOPAEDICS, LLC
PONTIS ORTHOPAEDICS, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010034074 | 3010034074 | PONTIS ORTHOPAEDICS, LLC | 1 | Y | 2020-04-25 | 2299 Post St Ste 207 San Francisco CA US 94115 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00859210006018 | PONTiS Flexor Tendon Repair System - 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. | 415-567-8935 | info@pontisorthopaedics.com |
| 00859210006025 | PONTiS Flexor Tendon Repair System - 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. | 415-567-8935 | info@pontisorthopaedics.com |
| 00859210006032 | PONTiS Flexor Tendon Repair System - 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. | 415-567-8935 | info@pontisorthopaedics.com |
| 00859210006049 | PONTiS Flexor Tendon Repar System - "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. " | 415-567-8935 | info@pontisorthopaedic.com |
| 00859210006070 | PONTiS Achilles Tendon Repair System - 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. | 415-567-8935 | info@pontisorthopaedics.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 150314 | 1680778742 | K141711 | PONTIS 3MM SUTURE ANCHORS WITH ULTRA-HIGH MOLECULAR WEIGHT POLYETHYLENE SUTURE, PONTIS ULTRA-HIGH MOLECULAR WEIGHT POLYE | MBI | 2014-07-24 |
| 150314 | 1761125550 | K140127 | FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP | GAQ | 2014-05-28 |
| 150314 | 1803997265 | K133579 | MULTIFILAMENT STAINLESS STEEL SUTURES WITH CRIMPS | MBI | 2014-06-26 |
| 150314 | 1453455970 | K101126 | PONTIS SUTURES AND SUTURE ANCHORS WITH OPTIONAL CRIMPS | MBI | 2010-12-02 |
| 150314 | 1029305904 | K081060 | FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 | GAQ | 2008-12-24 |
Product Codes Associated With Registrations#
PMN#
FERROFIBRE STAINLESS STEEL SUTURE WITH CRIMP
PONTIS ORTHOPAEDICS, LLC
GUDID#
PONTiS Flexor Tendon Repair System - 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.
2016-09-01
PONTiS Flexor Tendon Repair System - 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.
2016-09-01
PONTiS Achilles Tendon Repair System - 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.
2016-09-01
PONTiS Suture-Crimp Implant - 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
2017-09-12
PONTiS Flexor Tendon Repair System - 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.
2016-09-01
PONTiS Suture-Crimp Implant - PONTiS Suture-Crimp Implant kit with Multifilament Stainless Steel Sutures and SS Crimp Each Kit contains: 1x #3-0 MFSS suture with 2 straight needles (white wrap) 1x #3-0 MFSS suture with 2 straight needles (black wrap) 1x SS Crimp collar Supplied pouched, sterilized with EO
2016-11-18
PONTiS Flexor Tendon Repair System - 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.
2016-09-01
PONTiS Flexor Tendon Repar System - "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. "
2016-09-01