Company ยท US
Orthopaedic Biosystems, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1991 to 2000. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JDR | Staple, Fixation, Bone | 4 |
| MBI | Fastener, Fixation, Nondegradable, Soft Tissue | 3 |
| HWC | Screw, Fixation, Bone | 2 |
| HTN | Washer, Bolt Nut | 1 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 1 |
| JDW | Pin, Fixation, Threaded | 1 |
| LXT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | 1 |
| LZJ | Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 3, 2000 | K000797 | OBL 2.0 MM MINI TAC ANCHOR, MODEL 10-1629-01 Orthopaedic Biosystems, Ltd. | JDR |
| Mar 4, 1999 | K982996 | POLYMER OBL SB ANCHOR / SUTURE COMBINATION Orthopaedic Biosystems, Ltd. | JDR |
| Dec 16, 1998 | K983169 | POLYMER THREADED ANCHOR Orthopaedic Biosystems, Ltd. | MBI |
| Nov 20, 1998 | K982963 | POLYMER THREADED ANCHOR / SUTURE COMBINATION Orthopaedic Biosystems, Ltd. | JDI |
| Feb 6, 1998 | K972326 | PEBA ANCHOR/SUTURE COMBINATION Orthopaedic Biosystems, Ltd. | MBI |
| Nov 15, 1996 | K963420 | CANCELLOUS SCREW WASHER Orthopaedic Biosystems, Ltd. | HTN |
| Nov 13, 1996 | K963432 | GUIDE WIRES FOR CANNULATED SCREWS Orthopaedic Biosystems, Ltd. | LXT |
| Nov 6, 1996 | K963433 | THREADED FIXATION PIN Orthopaedic Biosystems, Ltd. | JDW |
| Aug 23, 1996 | K962779 | COMPRESSION SCREW Orthopaedic Biosystems, Ltd. | HWC |
| Oct 31, 1995 | K951451 | PEBA ANCHOR (MULTIPLE SIZES) Orthopaedic Biosystems, Ltd. | MBI |
| Aug 25, 1995 | K942889 | SB ANCHOR Orthopaedic Biosystems, Ltd. | JDR |
| Aug 12, 1994 | K932041 | XANCHOR SUTURE ATTACHMENT DEVICE Orthopaedic Biosystems | JDR |
| Mar 12, 1993 | K922788 | BIOACTION LOW PROFILE SCREW SYSTEM Orthopaedic Biosystems | HWC |
| Jun 28, 1991 | K911552 | ANATOMIC TOE SYSTEM Orthopaedic Biosystems | LZJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||