Search Results
Found 3 results
510(k) Data Aggregation
K Number
K192156Device Name
Cartiva SCI instrumentation set
Manufacturer
Cartiva, Inc.
Date Cleared
2019-09-04
(26 days)
Product Code
QBO
Regulation Number
888.4505Why did this record match?
Applicant Name (Manufacturer) :
Cartiva, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orthopedic surgical instrumentation supplied by Cartiva, Inc. is indicated for use in the press-fit fixation of the implantable medical device products manufactured by Cartiva, Inc.
Device Description
Orthopedic surgical instruments designed for osteochondral implants with press-fit fixation are devices intended to manipulate bone and cartilage tissue or the implant for the positioning, alignment, defect creation, and placement of press-fit osteochondral implants that utilize no additional means of fixation (e.g., suture fixation, adhesives). This type of device includes instruments specific to the geometry of the implant.
Ask a Question
K Number
K181348Device Name
Cartiva SCI Disposable Instrumentation Set
Manufacturer
Cartiva, Inc.
Date Cleared
2018-06-20
(30 days)
Product Code
QBO
Regulation Number
888.4505Why did this record match?
Applicant Name (Manufacturer) :
Cartiva, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Orthopedic surgical instrumentation supplied by Cartiva, Inc. is indicated for use in the press-fit fixation of the implantable medical device products manufactured by Cartiva, Inc.
Device Description
Orthopedic surgical instruments designed for osteochondral implants with press-fit fixation are hand-held devices intended to manipulate bone and cartilage tissue or the implant for the positioning, alignment, defect creation, and placement of press-fit osteochondral implants that utilize no additional means of fixation (e.g., suture fixation, adhesives). This type of device includes instruments specific to the geometry of the implant.
Ask a Question
K Number
K142490Device Name
ProxiFuse Hammer Toe Device
Manufacturer
Cartiva, Inc.
Date Cleared
2014-12-15
(102 days)
Product Code
HWC, HTY
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Cartiva, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ProxiFuse Hammer Toe Device is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Patients should be protected weight-bearing or heel-bearing until fusion or healing has occurred.
Device Description
The ProxiFuse Hammer Toe Device consists of three components: 1) the implant, 2) deployment instrumentation, and 3) bone awl. The implant is comprised of 2-0 suture, two Nitinol anchors with PEEK Inserts, and a PEEK Stabilizing Body. The device is delivered through a specifically designed instrument. The method of delivery allows for a shifting of the PEEK Body which limits the amount of traction required to place the middle phalanx over the device. The suture utilized in the device serves multiple functions: 1) shifting of the PEEK Body and 2) applying tension between the Nitinol anchors which in turn stabilizes the proximal interphalangeal joint (PIPJ).
Ask a Question
Page 1 of 1