Search Results
Found 2 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?
Product Code :
QBO
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?
Product Code :
QBO
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
Page 1 of 1