Panels › Orthopedic › Product code KWQ · Class 2
Appliance, Fixation, Spinal Intervertebral Body
Regulation 888.3060
11510(k)s in 12 months (668 all time)
1recalls in 12 months (214 all time)
165recalls that name a 510(k)
Top companies in KWQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Spine | 6 | 38 |
| Alphatec Spine, Inc. | 9 | 32 |
| RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | 0 | 41 |
| Zimmer, Inc. | 1 | 37 |
| Medtronic Sofamor Danek | 29 | 8 |
| Nuvasive, Inc. | 21 | 0 |
| K2m | 20 | 0 |
| Depuy Spine, Inc. | 10 | 8 |
| Blackstone Medical, Inc. | 13 | 3 |
| Globus Medical, Inc. | 15 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 29, 1992 | K914362 | TOP CERVICAL SPINE PLATES & TITANIUM BONE SCREWS Acorn Group, Inc. | KWQ |
| Mar 12, 1992 | K913730 | AESCULAP TITANIUM BONE PLATES Aesculap, Inc. | KWQ |
| Feb 3, 1992 | K910874 | THORACIC ANTERIOR SPINAL FIXATION PLATE Terray Manufacturing, Inc., CA | KWQ |
| Jan 31, 1992 | K905023 | AMSET LOCKING PLATE SYSTEM Advanced Med/Surg, Inc. | KWQ |
| Jan 28, 1992 | K901507 | MCAFFEE UNIVERSAL SPINAL SYSTEM (MUSS) Kirschner Medical Corp. | KWQ |
| Oct 4, 1991 | K910681 | SIMMONS PLATING SYSTEM Smith & Nephew Richards, Inc. | KWQ |
| Sep 5, 1991 | K904446 | CASF (TM) (CONTOURED ANTERIOR SPINAL FIXATON SYS.) Acromed Corp. | KWQ |
| Nov 30, 1988 | K873826 | ACROMED/KANEDA ANTERIOR SPINAL INSTRUMENTATION Acromed Corp. | KWQ |
| Sep 24, 1985 | K853033 | HARTSHILL RECT & WIRES, SPINAL FIXATION SYSTEM A.W. Showell (Surgicraft) , Ltd., GB | KWQ |
| Jun 28, 1985 | K851414 | SEGMENTAL SPINAL RODS Stuart | KWQ |
| May 16, 1984 | K841189 | OEC/REZAIAN SPINAL FIXATOR Orthopedic Equipment Co., Inc. | KWQ |
| Sep 20, 1983 | K831982 | BRADFORD SPINAL FRACTURE FIXATION SYS Depuy, Inc. | KWQ |
| Mar 11, 1982 | K820034 | ANTERIOR DISTRACTION SYSTEM Stuart | KWQ |
| Oct 10, 1980 | K802222 | ANTERIOR KYPHOSIS DISTRACTION DEVICE Zimmer, Inc. | KWQ |
| Dec 6, 1979 | K792352 | SYNTHES CERVICAL VERTABRAE PLATES DePuy Synthes | KWQ |
| May 23, 1979 | K790941 | D.T.T. LOCK SCREW INSERTER Depuy, Inc. | KWQ |
| Mar 21, 1979 | K790404 | DTT SYSTEM Depuy, Inc. | KWQ |
| Mar 21, 1979 | K782061 | SPINAL SURGERY INSTRUMENTATION Stuart Drug & Surgical Supply, Inc. | KWQ |
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