Avanta Orthopaedics, Inc.
San Diego, CA, US
Avanta Orthopaedics, Inc. appears in FDA device records in San Diego, CA. FDA records list 18 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 18 510(k) clearances for Avanta Orthopaedics, Inc. between 1997 and 2003. The busiest year on record is 1998, with 5. The most recent is 2003, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1997 | 3 |
| 1998 | 5 |
| 1999 | 1 |
| 2000 | 1 |
| 2001 | 4 |
| 2002 | 3 |
| 2003 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K030881 | AVANTA CARPAL FUSION PLATING SYSTEM | HRS | Substantially Equivalent | |
| K021859 | WRIST IMPLANT | JWJ | Substantially Equivalent | |
| K023604 | MODIFICATION TO RADIAL HEAD IMPLANT | KWI | Substantially Equivalent | |
| K013629 | FINGER JOINT PROSTHESIS | KYJ | Substantially Equivalent | |
| K011819 | RADIAL HEAD IMPLANT | KWI | Substantially Equivalent | |
| K010847 | K'FIX | NDL | Substantially Equivalent | |
| K003033 | SCAPHIX, STAPLE, FIXATION, BONE | JDR | Substantially Equivalent | |
| K010786 | ULNAR HEAD IMPLANT | KXE | Substantially Equivalent | |
| K002644 | RADIAL HEAD IMPLANT | KWI | Substantially Equivalent | |
| K990596 | DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM | HRS | Substantially Equivalent | |
| K982268 | ULNAR HEAD IMPLANT | KXE | Substantially Equivalent | |
| K982288 | RADIAL HEAD IMPLANT | KWI | Substantially Equivalent | |
| K981715 | DISTAL RADIUS FRACTURE FIXATION PLATE | HRS | Substantially Equivalent | |
| K981716 | EXTERNAL FIXATION | JDW | Substantially Equivalent | |
| K974911 | EXTERNAL FIXATOR | JDW | Substantially Equivalent | |
| K965204 | AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT | KYI | Substantially Equivalent for Some Indications | |
| K964359 | AVANTA ORTHOPAEDICS TENDON SPACER | HXA | Substantially Equivalent | |
| K964381 | AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT | KYI | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- NDLPin, Fixation, Smooth, Metallic
- JDWPin, Fixation, Threaded
- HRSPlate, Fixation, Bone
- KWIProsthesis, Elbow, Hemi-, Radial, Polymer
- KYJProsthesis, Finger, Constrained, Polymer
- HXAProsthesis, Tendon, Passive
- JWJProsthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
- KYIProsthesis, Wrist, Carpal Trapezium
- KXEProsthesis, Wrist, Hemi-, Ulnar
- JDRStaple, Fixation, Bone
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0710-03 | Finger Joint Implants, Silicone Models TRL-10 and TRL-20 | Wrong silicone elastomer used in construction. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain