Search Results
Found 18 results
510(k) Data Aggregation
K Number
K030881Device Name
AVANTA CARPAL FUSION PLATING SYSTEM
Manufacturer
AVANTA ORTHOPAEDICS, INC.
Date Cleared
2003-04-10
(21 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
AVANTA ORTHOPAEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Avanta carpal fusion plate is designed for fusion of the carpal bones of the hand including; capitate, hamate, lunate, and triquetrum. The fusion plate is intended for use in patients suffering from pain and/or loss of function due to osteoarthritis, post-traumatic arthritis, fractures, revision of failed partial wrist fusions, carpal instability, or rheumatoid arthritis. The fusion plate is used in conjunction with screws that fix the plate to the carpal bones of the hand.
Device Description
The Avanta carpal fusion plate is a low profile single piece construct designed to fit over the dorsal aspect of the carpal bones in the hand. The plate has spherical holes or slots that accommodate screws for fixation. The plate and screws are fabricated from implantable grade stainless steel.
Ask a Question
K Number
K021859Device Name
WRIST IMPLANT
Manufacturer
AVANTA ORTHOPAEDICS, INC.
Date Cleared
2002-12-02
(179 days)
Product Code
JWJ
Regulation Number
888.3800Why did this record match?
Applicant Name (Manufacturer) :
AVANTA ORTHOPAEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Avanta Orthopaedics Wrist implant is intended for replacement of the painful wrist joint due to rheumatoid arthritis, oseto-arthritis, or post-traumatic arthritis.
Device Description
The wrist implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the wrist.
Ask a Question
K Number
K023604Device Name
MODIFICATION TO RADIAL HEAD IMPLANT
Manufacturer
AVANTA ORTHOPAEDICS, INC.
Date Cleared
2002-11-27
(30 days)
Product Code
KWI
Regulation Number
888.3170Why did this record match?
Applicant Name (Manufacturer) :
AVANTA ORTHOPAEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Avanta Orthopaedics Radial Head implant is intended for replacement of the proximal end of the radius:
- Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with:
- joint destruction or subluxation visible on x-ray .
- resistance to conservative treatment .
- Primary replacement after fracture of the radial head .
- Symptomatic sequelae after radial head resection .
Device Description
The radial head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.
Ask a Question
K Number
K013629Device Name
FINGER JOINT PROSTHESIS
Manufacturer
AVANTA ORTHOPAEDICS, INC.
Date Cleared
2002-01-25
(81 days)
Product Code
KYJ, SUT
Regulation Number
888.3230Why did this record match?
Applicant Name (Manufacturer) :
AVANTA ORTHOPAEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Avanta Orthopaedics Finger Joint Prosthesis is intended for replacement of the Metacarpophalangeal joint of the hand which has been damaged by rheumatoid, osteo or post traumatic arthritis.
Device Description
The finger joint prosthesis like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the MCP joint of the hand.
Ask a Question
K Number
K010847Device Name
K'FIX
Manufacturer
AVANTA ORTHOPAEDICS, INC.
Date Cleared
2001-06-19
(90 days)
Product Code
NDL
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
AVANTA ORTHOPAEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K011819Device Name
RADIAL HEAD IMPLANT
Manufacturer
AVANTA ORTHOPAEDICS, INC.
Date Cleared
2001-06-19
(8 days)
Product Code
KWI, ORI
Regulation Number
888.3170Why did this record match?
Applicant Name (Manufacturer) :
AVANTA ORTHOPAEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Avanta Orthopaedics Radial Head implant is intended for replacement of the proximal end of the radius:
- Replacement of the radial head for degenerative, or post-traumatic disabilities presenting pain, crepitation and decreased motion at the radiohumeral and or proximal radio-ulnar joint with:
- joint destruction or subluxation visible on x-ray
- resistance to conservative treatment
- Primary replacement after fracture of the radial head
- Symptomatic sequelae after radial head resection
- Revision following failed radial head arthroplasty
Device Description
The radial head implant like the predicate device includes various sizes of implants and accessories including sizers. The implant allows for replacement of the proximal radial head.
Ask a Question
K Number
K003033Device Name
SCAPHIX, STAPLE, FIXATION, BONE
Manufacturer
AVANTA ORTHOPAEDICS, INC.
Date Cleared
2001-05-30
(244 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
AVANTA ORTHOPAEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K010786Device Name
ULNAR HEAD IMPLANT
Manufacturer
AVANTA ORTHOPAEDICS, INC.
Date Cleared
2001-04-11
(27 days)
Product Code
KXE
Regulation Number
888.3810Why did this record match?
Applicant Name (Manufacturer) :
AVANTA ORTHOPAEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K002644Device Name
RADIAL HEAD IMPLANT
Manufacturer
AVANTA ORTHOPAEDICS, INC.
Date Cleared
2000-11-20
(88 days)
Product Code
KWI
Regulation Number
888.3170Why did this record match?
Applicant Name (Manufacturer) :
AVANTA ORTHOPAEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
Ask a Question
K Number
K990596Device Name
DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM
Manufacturer
AVANTA ORTHOPAEDICS, INC.
Date Cleared
1999-04-29
(64 days)
Product Code
HRS, ACC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
AVANTA ORTHOPAEDICS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the distal radius fracture fixation plate system is internal fixation of fractures and osteotomies of the distal radius. This may include:
- Displaced or non-displaced fracture which may or may not involve angulation or . fragmentation of bone,
- Failed fracture fixation with or without bone graft, ●
- Osteotomy and repair of distal radius malunion with or without bone graft. .
Device Description
The distal radius plate like the predicate device includes various size plates, right, left, small, large, accessories and instruments. The bone screws enable the plate to be coupled to bone by securing the screws for the intended use. The various components within the system are provided to accommodate various anatomies and injuries.
Ask a Question
Page 1 of 2