Panels › Orthopedic › Product code NKB · Class 2
Thoracolumbosacral Pedicle Screw System
Regulation 888.3070
33510(k)s in 12 months (914 all time)
4recalls in 12 months (182 all time)
177recalls that name a 510(k)
Top companies in NKB
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 98 | 2 |
| Depuy Spine, Inc. | 30 | 10 |
| Nuvasive, Inc. | 9 | 31 |
| Spinal Elements, Inc. | 11 | 22 |
| Stryker Spine | 22 | 5 |
| Alphatec Spine, Inc. | 20 | 5 |
| Zimmer Biomet, Inc. | 0 | 25 |
| Globus Medical, Inc. | 24 | 0 |
| Life Spine | 22 | 0 |
| K2m | 20 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 70mm Straight Rod,
Part Number: 60101-070.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 60mm Straight Rod,
Part Number: 60101-060.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 50mm Straight Rod,
Part Number: 60101-050.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 40mm Straight Rod,
Part Number: 60101-040.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 30mm Straight Rod,
Part Number: 60101-030.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 120mm Lordosed Rod,
Part Number: 60100-120.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 110mm Lordosed Rod,
Part Number: 60100-110.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 100mm Lordosed Rod,
Part Number: 60100-100.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 90 MM Lordosed Rod,
Part Number: 60100-090.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 80 MM Lordosed Rod,
Part Number: 60100-080.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 70 MM Lordosed Rod,
Part Number: 60100-070.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 60 MM Lordosed Rod,
Part Number: 60100-060.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 50 MM Lordosed Rod,
Part Number: 60100-050.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 40 MM Lordosed Rod,
Part Number: 60100-040.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| May 7, 2013 | Spinal Elements, Inc Mercury Spinal System DIA 5.5 x 30 MM Lordosed Rod,
Part Number: 60100-030.
Intended to provide immobilization and stabilization of the spine in skeletally mature patients. Terminated |
NKB | K071914 |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl
Product Code: 1867-15-199
Spinal Implant Component. Terminated |
NKB | K101993 |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl
Product Code: 1867-15-180
Spinal Implant Component. Terminated |
NKB | K101993 |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl
Product Code: 1867-15-170
Spinal Implant Component. Terminated |
NKB | None listed |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl
Product Code: 1867-15-999
Spinal Implant Component. Terminated |
NKB | K101993 |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl
Product Code: 1867-15-980
Spinal Implant Component. Terminated |
NKB | K101993 |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl
Product Code: 1867-15-970
Spinal Implant Component. Terminated |
NKB | K101993 |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl
Product Code: 1867-15-899
Spinal Implant Component. Terminated |
NKB | K101993 |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl
Product Code: 1867-15-880
Spinal Implant Component. Terminated |
NKB | K101993 |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl
Product Code: 1867-15-870
Spinal Implant Component. Terminated |
NKB | K101993 |
| Nov 19, 2012 | NuVasive Inc 7.5mm x 50mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 7.5mm x 45mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 7.5mm x 40mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 6.5mm x 50mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 6.5mm x 45mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 6.5mm x 40mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 5.5mm x 50mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 5.5mm x 45mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 5.5mm x 40mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 4.5mm x 40mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 4.5mm x 35mm Noncannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc Screw Tulip , 5.5mm Rod
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 7.5mm x 55mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 7.5mm x 50mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 7.5mm x 45mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 7.5mm x 40mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 7.5mm x 35mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 7.5mm x 30mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 6.5mm x 55mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 6.5mm x 50mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 6.5mm x 45mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 6.5mm x 40mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 6.5mm x 35mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 6.5mm x 30mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 5.5mm x 55mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
| Nov 19, 2012 | NuVasive Inc 5.5mm x 50mm Cannulated Screw Shank
Subsequent Codes: KWP, KWQ, MNH, MNI Terminated |
NKB | K082332 |
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