Company ยท US
Avanta Orthopaedics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2003. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | 4 |
| HRS | Plate, Fixation, Bone | 3 |
| KYI | Prosthesis, Wrist, Carpal Trapezium | 3 |
| JDW | Pin, Fixation, Threaded | 2 |
| KXE | Prosthesis, Wrist, Hemi-, Ulnar | 2 |
| HXA | Prosthesis, Tendon, Passive | 1 |
| JDR | Staple, Fixation, Bone | 1 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | 1 |
| KYJ | Prosthesis, Finger, Constrained, Polymer | 1 |
| NDL | Pin, Fixation, Smooth, Metallic | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 10, 2003 | K030881 | AVANTA CARPAL FUSION PLATING SYSTEM Avanta Orthopaedics, Inc. | HRS |
| Dec 2, 2002 | K021859 | WRIST IMPLANT Avanta Orthopaedics, Inc. | JWJ |
| Nov 27, 2002 | K023604 | MODIFICATION TO RADIAL HEAD IMPLANT Avanta Orthopaedics, Inc. | KWI |
| Jan 25, 2002 | K013629 | FINGER JOINT PROSTHESIS Avanta Orthopaedics, Inc. | KYJ |
| Jun 19, 2001 | K011819 | RADIAL HEAD IMPLANT Avanta Orthopaedics, Inc. | KWI |
| Jun 19, 2001 | K010847 | K'FIX Avanta Orthopaedics, Inc. | NDL |
| May 30, 2001 | K003033 | SCAPHIX, STAPLE, FIXATION, BONE Avanta Orthopaedics, Inc. | JDR |
| Apr 11, 2001 | K010786 | ULNAR HEAD IMPLANT Avanta Orthopaedics, Inc. | KXE |
| Nov 20, 2000 | K002644 | RADIAL HEAD IMPLANT Avanta Orthopaedics, Inc. | KWI |
| Apr 29, 1999 | K990596 | DISTAL RADIUS FRACTURE FIXATION PLATE SYSTEM Avanta Orthopaedics, Inc. | HRS |
| Dec 4, 1998 | K982268 | ULNAR HEAD IMPLANT Avanta Orthopaedics, Inc. | KXE |
| Sep 8, 1998 | K982288 | RADIAL HEAD IMPLANT Avanta Orthopaedics, Inc. | KWI |
| Jul 29, 1998 | K981715 | DISTAL RADIUS FRACTURE FIXATION PLATE Avanta Orthopaedics, Inc. | HRS |
| Jul 17, 1998 | K981716 | EXTERNAL FIXATION Avanta Orthopaedics, Inc. | JDW |
| Mar 16, 1998 | K974911 | EXTERNAL FIXATOR Avanta Orthopaedics, Inc. | JDW |
| Jun 3, 1997 | K965204 | AVANTA ORTHOPAEDICS TRAPEZIUM IMPLANT Avanta Orthopaedics, Inc. | KYI |
| Mar 25, 1997 | K964359 | AVANTA ORTHOPAEDICS TENDON SPACER Avanta Orthopaedics, Inc. | HXA |
| Jan 22, 1997 | K964381 | AVANTA ORTHOPAEDICS TRAPEZIAL IMPLANT Avanta Orthopaedics, Inc. | KYI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2003 | Avanta Orthopaedics, Inc. Finger Joint Implants, Silicone
Models TRL-10 and TRL-20 Terminated |
KYI | K964381 |