Search Results
Found 723 results
510(k) Data Aggregation
(29 days)
Re: K253125
Trade/Device Name: Parietene™ Flat Sheet Mesh
Regulation Number: 21 CFR 878.3300
Mesh, Surgical, Polymeric
Panel number and product code: 79 FTL
Regulation number: 21 CFR 878.3300
Mesh, Surgical, Polymeric
Panel number and product code: 79 FTL
Regulation number: 21 CFR 878.3300
Parietene™ flat Sheet Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernias repair.
Parietene™ Flat Sheet Mesh is a Monofilament polypropylene mesh.
N/A
Ask a specific question about this device
(30 days)
.:** 1320894
Regulatory Class: Class II, 21 CFR 888.3030, 21 CFR 878.3300
Review Panel: Orthopedics
K242187
Device: BioBrace®
Common Name: Surgical Mesh
Regulatory Class: Class II, 21 CFR 878.3300
The BioBrace® Extra-Articular Ligament Augmentation Kit is intended to reattach soft tissue to bone and reinforce soft tissue where weakness exists in extra-articular knee ligament surgical procedures.
The Argo Knotless® GENESYS™ Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.
The BioBrace® Reinforced BioInductive Implant is intended for reinforcement of soft tissues that are repaired by suture or suture anchors during knee repair surgery including reinforcement of patellar ligament, medial collateral ligament, lateral collateral ligament or other knee extra-articular ligaments. It is not intended to replace normal body structures or provide the full mechanical strength to the repair. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.
The BioBrace® Extra-Articular Ligament Augmentation Kit is a single-use augmentation procedure kit for use in general surgical procedures for BioBrace® Reinforced BioInductive Implant ("BioBrace® implant") reinforcement of soft tissue where weakness exists, specifically in the extra-articular knee ligaments.
The kit is comprised of bioabsorbable implants and instrumentation. The kit includes one (1) tapered BioBrace Implant 5x250mm, which is threaded through the anchor eyelet.
Kit components are assembled in a single PETG tray and retainer then sealed in a Tyvek pouch. The BioBrace® Extra-Articular Ligament Augmentation Kit is supplied sterile (ETO).
Identical to K240090
Argo Knotless® GENESYS™ Anchor: The Non-Self-Punching Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10-6. The anchor configuration requires a pre-prepared bone hole. The threaded anchor is manufactured of bioabsorbable material, and the suture eyelet is manufactured of PEEK material. Each size features a single use driver, a threaded anchor, a PEEK suture eyelet, a #2 UHMWPE, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. The suture eyelet can hold up to six (6) sutures. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.
Identical to K244025
Argo Knotless® GENESYS™ Anchor: The Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10-6. The threaded anchor is manufactured of bioabsorbable material, and the suture eyelet is manufactured of PEEK Optima material. The device features a single use driver, a threaded anchor, a PEEK-Optima eyelet, a #2 UHMWPE, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. The suture eyelet can hold up to six (6) sutures or one (1) bioresorbable reinforced implant. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.
Identical to K242187
BioBrace® is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists.
BioBrace® is also intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. BioBrace® is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.
N/A
Ask a specific question about this device
(120 days)
34108
Re: K251690
Trade/Device Name: Arthrex SpeedFLEX™ Implant
Regulation Number: 21 CFR 878.3300
Reinforcement of Tendon
Product Code:
Primary: OWY
Additional: GAT
Classification Name:
CFR 878.3300
The Arthrex SpeedFLEX™ Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The Arthrex SpeedFLEX™ Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including but not limited to reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The Arthrex SpeedFLEX™ Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.
The Arthrex SpeedFLEX™ Implant consists of a decellularized human allograft dermis that is pre-sutured with FiberWire® suture (passing suture) and TigerLink™ SutureTape (implanted). The allograft implant will be offered in four (4) sizes. The Arthrex SpeedFLEX™ Implant is sold sterile, single use.
N/A
Ask a specific question about this device
(29 days)
23508
Re: K252647
Trade/Device Name: Tapestry Biointegrative Implant
Regulation Number: 21 CFR 878.3300
Ask a specific question about this device
Page 1 of 73