Company ยท US
Orthopedic Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1996. Name variants (Inc, Corp, punctuation) are merged.
95510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| FWZ | Operating Room Accessories Table Tray | 9 |
| HST | Apparatus, Traction, Non-Powered | 8 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | 7 |
| HRX | Arthroscope | 6 |
| HWC | Screw, Fixation, Bone | 4 |
| KQX | Goniometer, Ac-Powered | 3 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | 3 |
| GEY | Motor, Surgical Instrument, Ac-Powered | 2 |
| HXY | Brace, Drill | 2 |
| IKK | System, Isokinetic Testing And Evaluation | 2 |
| IQM | Splint, Temporary Training | 2 |
| ITQ | Joint, Knee, External Brace | 2 |
| JDG | Prosthesis, Hip, Femoral Component, Cemented, Metal | 2 |
| JEA | Table, Surgical With Orthopedic Accessories, Ac-Powered | 2 |
| JEB | Table, Surgical With Orthopedic Accessories, Manual | 2 |
| LXH | Orthopedic Manual Surgical Instrument | 2 |
| CAI | Circuit, Breathing (W Connector, Adaptor, Y Piece) | 1 |
| EAJ | Apron, Leaded | 1 |
| FEF | Tube, Single Lumen, With Mercury Wt Balloon For Intestinal Intubation And / Or Decompression | 1 |
| FNJ | Bed, Manual | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 22, 1996 | K952495 | ANCHORS AWAY SOFT TISSUE ATTACHMENT SYSTEM Orthopedic Systems, Inc. | LXH |
| Aug 10, 1992 | K920256 | SPINE MOTION ANALYZER WITH EMG Orthopedic Systems, Inc. | KQX |
| May 21, 1991 | K910736 | JACKSON MULTIPURPOSE OPERATING TABLE Orthopedic Systems, Inc. | JEA |
| Jan 24, 1991 | K910031 | PARK CITY SHOULDER POSITIONER Orthopedic Systems, Inc. | FWZ |
| Jan 4, 1991 | K903938 | C FIT CUP Orthopedic Systems, Inc. | JDI |
| May 4, 1990 | K892503 | NUFFIELD TOTAL KNEE Orthopedic Systems, Inc. | JWH |
| Jan 30, 1990 | K896678 | SILICONE PLUG Orthopedic Systems, Inc. | HRX |
| Jan 19, 1990 | K894283 | COMPREHENSIVE SPINE MOTION ANALYZER Orthopedic Systems, Inc. | KQX |
| Oct 13, 1989 | K890498 | FREEMAN MODULAR HIP STEM RIDGED VERSION Orthopedic Systems, Inc. | JDI |
| Oct 13, 1989 | K890331 | FREEMAN TOTAL HIP SYSTEM RIDGED STEM Orthopedic Systems, Inc. | LWJ |
| Sep 12, 1989 | K895219 | CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM Orthopedic Systems, Inc. | HWC |
| Sep 12, 1989 | K895218 | CANCELLOUS SCREW SHORT THREAD DIAMETER 6.5MM Orthopedic Systems, Inc. | HWC |
| Sep 12, 1989 | K895217 | CORTICAL SCREW Orthopedic Systems, Inc. | HWC |
| Aug 3, 1989 | K894249 | UNIVERSAL CEMENTED CUP Orthopedic Systems, Inc. | JDI |
| Jun 8, 1989 | K891539 | CTI II STRAIGHT STEM Orthopedic Systems, Inc. | LWJ |
| May 15, 1989 | K891903 | COHN TARGETEER Orthopedic Systems, Inc. | LXH |
| Apr 6, 1989 | K890187 | THE C-S DISTRACTION ROD ASSEMBLY Orthopedic Systems, Inc. | KWP |
| Apr 6, 1989 | K890185 | C-S IMPACTOR Orthopedic Systems, Inc. | LYP |
| Jan 30, 1989 | K875130 | BONE NAIL W/WASHER & AN ARTHROSCOPIC INSERTION SYS Orthopedic Systems, Inc. | HRX |
| Jan 18, 1989 | K884483 | CRUCIOMETER Orthopedic Systems, Inc. | JZE |
| Dec 22, 1988 | K884641 | BOVAC SMOKE COLLECTOR Orthopedic Systems, Inc. | GEI |
| Aug 26, 1988 | K883457 | ASST-3000 SPINAL SURGERY TABLE Orthopedic Systems, Inc. | FWY |
| Jun 30, 1988 | K881511 | FIXATOR PIN (EXTERNAL) Orthopedic Systems, Inc. | JDW |
| Jun 29, 1988 | K881289 | CORIN BIPOLAR PROSTHESIS Orthopedic Systems, Inc. | KWY |
| Jun 29, 1988 | K881288 | CORIN MODULAR MOORE STEM Orthopedic Systems, Inc. | LWJ |
| Apr 14, 1988 | K880203 | HERMAN CANNULA SET Orthopedic Systems, Inc. | HRX |
| Mar 25, 1988 | K881060 | OSI RIZZOLI TRAUMA TABLE (ELECTRIC VERSION) Orthopedic Systems, Inc. | JEA |
| Mar 23, 1988 | K880264 | BONE SUTURE FIXATION DEVICE Orthopedic Systems, Inc. | HXY |
| Mar 15, 1988 | K880263 | OSI RIZZOLI ORTHOPEDIC TABLE/MANUAL VERSION Orthopedic Systems, Inc. | JEB |
| Mar 11, 1988 | K880253 | BLAKEMORE RETAINER Orthopedic Systems, Inc. | FEF |
| Feb 18, 1988 | K880265 | WEHBE ARM HOLDER Orthopedic Systems, Inc. | FWZ |
| Jan 29, 1988 | K874616 | MOORE HIP PROSTHESIS FENESTRATED STEM Orthopedic Systems, Inc. | JDI |
| Jan 29, 1988 | K874599 | MOORE HIP PROSTHESIS SOLID STEM Orthopedic Systems, Inc. | JDI |
| Jan 19, 1988 | K875235 | ISOKINETIC SYSTEM, TESTING AND EVALUATION Orthopedic Systems, Inc. | IKK |
| Jan 6, 1988 | K873660 | ROPER-TUKE ELBOW Orthopedic Systems, Inc. | JDB |
| Dec 31, 1987 | K873626 | FREEMAN TOTAL HIP SYSTEM TITANIUM MODULAR SYSTEM Orthopedic Systems, Inc. | JDI |
| Dec 30, 1987 | K873627 | CTI STRAIGHT STEM Orthopedic Systems, Inc. | JDG |
| Dec 10, 1987 | K874617 | THOMPSON HIP PROSTHESIS Orthopedic Systems, Inc. | JDG |
| Dec 7, 1987 | K874130 | TITANIUM BONE SCREWS Orthopedic Systems, Inc. | HWC |
| Dec 7, 1987 | K873632 | HI-NEK TOTAL HIP Orthopedic Systems, Inc. | JDI |
| Nov 6, 1987 | K874300 | AESTHESIOMETER Orthopedic Systems, Inc. | GWI |
| May 1, 1987 | K871323 | ARTHROSCOPIC MENISCAL SUTURE SYSTEM Orthopedic Systems, Inc. | HWT |
| Apr 15, 1987 | K871287 | ORTHOPEDIC DRILL GUIDE Orthopedic Systems, Inc. | HSZ |
| Apr 7, 1987 | K871225 | HAND SURGERY TABLE EXTENSION Orthopedic Systems, Inc. | FWZ |
| Feb 6, 1987 | K870105 | INFANT CAST TABLE Orthopedic Systems, Inc. | |
| Feb 6, 1987 | K870104 | RADIOLUCENT TABLE EXTENSION Orthopedic Systems, Inc. | FWZ |
| Feb 6, 1987 | K870101 | CLARK SOCKET, SIDE RAIL SOCKET, SIDE RAIL SECTION Orthopedic Systems, Inc. | FWZ |
| Feb 6, 1987 | K870099 | PIVOTING SURGICAL ARM BOARDS Orthopedic Systems, Inc. | |
| Feb 6, 1987 | K870098 | LITHOTOMY HOLDERS Orthopedic Systems, Inc. | FWZ |
| Feb 4, 1987 | K870125 | EXTREMITY ELEVATOR Orthopedic Systems, Inc. | HST |
Newest 50 of 95.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2007 | Orthopedic Systems Inc Doro Products Adapter, Product number 5979-300. The adaptor system is attached to OSI''s Spinal Frame, which is an operating room tabletop that is attached to a table base. The Frame is used to supp Terminated |
FWZ | None listed |