Company ยท US
Warsaw Orthopedic, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1989. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
10recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| HWC | Screw, Fixation, Bone | 7 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 6 |
| HRX | Arthroscope | 3 |
| HWR | Driver, Prosthesis | 2 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 2 |
| FNJ | Bed, Manual | 1 |
| HRS | Plate, Fixation, Bone | 1 |
| HSB | Rod, Fixation, Intramedullary And Accessories | 1 |
| HTO | Reamer | 1 |
| HTP | File | 1 |
| HWB | Extractor | 1 |
| HWP | Punch, Femoral Neck | 1 |
| HWT | Template | 1 |
| JDR | Staple, Fixation, Bone | 1 |
| JDW | Pin, Fixation, Threaded | 1 |
| KTW | Appliance, Fixation, Nail/Blade/Plate Combination, Single Component | 1 |
| LYQ | Accessories, Fixation, Spinal Intervertebral Body | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 15, 1989 | K892877 | CRADLE, HOSPITAL BED CLOTHING Warsaw Orthopedic, Inc. | FNJ |
| Apr 6, 1989 | K883784 | TSRH ANTERIOR SPINAL SCREWS, STAPLES AND END PLATE Warsaw Orthopedic, Inc. | LYQ |
| Apr 6, 1989 | K883783 | TSRH SACRAL SPINAL SCREW Warsaw Orthopedic, Inc. | KWP |
| Mar 4, 1988 | K880212 | TSRH H/M HOOK HOLDER W/ROD MOVER Warsaw Orthopedic, Inc. | KWP |
| Mar 4, 1988 | K880211 | TSRH H/M HOOK HOLDER Warsaw Orthopedic, Inc. | KWP |
| Feb 18, 1988 | K880215 | TSRH H/M HOOK, EYEBOLT/LOCK NUT ASSEM., SPINAL ROD Warsaw Orthopedic, Inc. | KWP |
| Feb 18, 1988 | K880214 | TSRH H/M TORQUE LIMITING WRENCH Warsaw Orthopedic, Inc. | KWP |
| May 27, 1987 | K870843 | SCHULTZ PHALANGEAL COMP TRIAL/METACARPAL COMP TRIA Warsaw Orthopedic, Inc. | HWT |
| May 27, 1987 | K870842 | SCHULTZ PHALANGEAL COMP RASP/METACARPAL COMP RASP Warsaw Orthopedic, Inc. | HTP |
| May 4, 1987 | K870830 | WARSAW ORTHOPEDIC TSR CROSS LINK SYSTEM Warsaw Orthopedic, Inc. | KWP |
| Mar 13, 1987 | K870848 | SCHULTZ METACARPAL COMPONENT DRIVER Warsaw Orthopedic, Inc. | HWR |
| Mar 13, 1987 | K870847 | SCHULTZ PHALANGEAL COMPONENT DRIVER Warsaw Orthopedic, Inc. | HWR |
| Mar 13, 1987 | K870846 | SCHULTZ MP COMPONENT PUNCH Warsaw Orthopedic, Inc. | HWP |
| Mar 13, 1987 | K870844 | SCHULTZ PROSTHESIS COMPONENT INSERTER EXTRACTOR Warsaw Orthopedic, Inc. | HWB |
| Mar 11, 1987 | K870845 | WARSAW ORTHOPEDIC POINTED REAMER Warsaw Orthopedic, Inc. | HTO |
| Mar 9, 1987 | K870727 | WARSAW ORTHOPEDIC I BONE PLATE Warsaw Orthopedic, Inc. | KTW |
| Jul 25, 1986 | K862311 | SCREW DRIVER/BONE SCREW WRENCH/TAP & GUIDE PIN Warsaw Orthopedic, Inc. | KTT |
| Jul 8, 1986 | K862254 | WARSAW ORTHOPEDIC BONE PLATE Warsaw Orthopedic, Inc. | HRS |
| Feb 11, 1986 | K860074 | SCHULTZ METACARPOPHALANGEAL JOINT PROSTHESIS Warsaw Orthopedic, Inc. | |
| Jun 28, 1985 | K851919 | SUPRACONDYLAR BONE PLATE Warsaw Orthopedic, Inc. | KTT |
| May 22, 1985 | K852026 | FEMORAL PROXIMAL DIAGNOSAL SCREW, FEMORAL TRANSVER Warsaw Orthopedic, Inc. | HWC |
| May 22, 1985 | K852020 | INTERLOCKING FEMORAL NAIL(LEFT & RIGHT) TIBIAL NAI Warsaw Orthopedic, Inc. | HSB |
| Aug 2, 1984 | K842293 | PARTIALLY THREADED BONE FIX. PIN Warsaw Orthopedic, Inc. | JDW |
| Oct 20, 1983 | K832884 | FIXATION STAPLE DRIVER/EXTRACTOR Warsaw Orthopedic, Inc. | JDR |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2005 | Warsaw Orthopedic, Inc. Medtronic Sofamor Danek brand LT CAGE lumbar tapered fusion device implant 14 mm x 17.5 mm x 23 mm; Catalog number 8941423. Terminated |
MAX | None listed |
| Jul 13, 2005 | Warsaw Orthopedic, Inc. Medtronic Sofamor Danek brand METRx System MD Procedure Kit; Ref 9560030. Terminated |
HRX | K993021 |
| Jul 13, 2005 | Warsaw Orthopedic, Inc. Medtronic Sofamor Danek brand METRx System 18 mm Med Procedure Kit; Ref 9560018. Terminated |
HRX | K993021 |
| Jul 13, 2005 | Warsaw Orthopedic, Inc. Medtronic Sofamor Danek brand METRx System 16 mm Med Procedure Kit; Ref 9560016. Terminated |
HRX | K993021 |
| Jan 28, 2005 | Warsaw Orthopedic, Inc. ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-145. Terminated |
HWC | None listed |
| Jan 28, 2005 | Warsaw Orthopedic, Inc. ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-142. Terminated |
HWC | None listed |
| Jan 28, 2005 | Warsaw Orthopedic, Inc. ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-140. Terminated |
HWC | None listed |
| Jan 28, 2005 | Warsaw Orthopedic, Inc. ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-127. Terminated |
HWC | None listed |
| Jan 28, 2005 | Warsaw Orthopedic, Inc. ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-125. Terminated |
HWC | None listed |
| Jan 28, 2005 | Warsaw Orthopedic, Inc. ATLANTIS Element Express Kit; a sterile kit for cervical spine surgery which includes hex-head screwdriver, bone plate and 4 bone screws; catalog number 786-123. Terminated |
HWC | None listed |