Panels › General, Plastic Surgery › Product code JDK · Class 2
Prosthesis, Hip, Cement Restrictor
Regulation 878.3300
0510(k)s in 12 months (54 all time)
0recalls in 12 months (12 all time)
11recalls that name a 510(k)
Top companies in JDK
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek USA, Inc. | 7 | 0 |
| Encore Medical, Lp | 0 | 6 |
| Osteonics Corp. | 6 | 0 |
| Depuy Orthopaedics, Inc. | 0 | 5 |
| Spinal Concepts, Inc. | 5 | 0 |
| Interpore Cross Intl. | 2 | 0 |
| Life Spine | 2 | 0 |
| Spine Next SA | 2 | 0 |
| Theken Surgical,Llc | 2 | 0 |
| Amedica Corp. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 29, 2024 | MEDLINE INDUSTRIES, LP - Northfield MEDLINE 4.5 IN WIRE CUT SCISSORS, Product Code DYND04006 Open, Classified |
JDK | None listed |
| Mar 17, 2011 | Depuy Orthopaedics, Inc. DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary canal during implantati Terminated |
JDK | K800894 |
| Mar 17, 2011 | Depuy Orthopaedics, Inc. DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 3, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary canal during implantati Terminated |
JDK | K800894 |
| Mar 17, 2011 | Depuy Orthopaedics, Inc. DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 5, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary canal during implantatio Terminated |
JDK | K800894 |
| Mar 17, 2011 | Depuy Orthopaedics, Inc. DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 4, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary canal during implantatio Terminated |
JDK | K800894 |
| Mar 17, 2011 | Depuy Orthopaedics, Inc. DePuy, a Johnson & Johnson company, CEMENT RESTRICTOR, Size 1, Sterile, DePuy Orthopaedics. This device is intended to restrict bone cement migration into the distal medullary canal during implantatio Terminated |
JDK | K800894 |
| Jan 9, 2008 | Encore Medical, Lp VariLift Bone Plug w/ End Cap; 15mm Dia, 24mm long; Ref #: CIE1-15-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758. Terminated |
JDK | K030608 |
| Jan 9, 2008 | Encore Medical, Lp VariLift Bone Plug w/ End Cap; 13mm Dia, 24mm long; Ref #: CIE1-13-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758. Terminated |
JDK | K030608 |
| Jan 9, 2008 | Encore Medical, Lp VariLift Bone Plug w/ End Cap; 11mm Dia, 24mm long; Ref #: CIE1-11-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758. Terminated |
JDK | K030608 |
| Jan 9, 2008 | Encore Medical, Lp VariLift Bone Plug w/ End Cap; 18mm Dia, 24mm long; Ref #: CEA1-18-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758. Terminated |
JDK | K030608 |
| Jan 9, 2008 | Encore Medical, Lp VariLift Bone Plug w/ End Cap; 16mm Dia, 24mm long; Ref #: CEA1-16-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758. Terminated |
JDK | K030608 |
| Jan 9, 2008 | Encore Medical, Lp VariLift Bone Plug w/ End Cap; 14mm Dia, 24mm long; Ref #: CEA1-14-24-BP; Sterile; Encore Orthopedics, Austin, TX 78758. Terminated |
JDK | K030608 |
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