Stryker Leibinger
Kalamazoo, MI, US
Stryker Leibinger appears in FDA device records in Kalamazoo, MI. FDA records list 13 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 13
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 13 510(k) clearances for Stryker Leibinger between 1999 and 2014. The busiest year on record is 2000, with 3. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1999 | 1 |
| 2000 | 3 |
| 2001 | 1 |
| 2002 | 1 |
| 2003 | 2 |
| 2004 | 2 |
| 2005 | 2 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K133974 | VARIAX DISTAL RADIUS PLATING SYSTEM | HRS | Substantially Equivalent | |
| K052871 | STRYKER CUSTOM TI IMPLANT | GXN | Substantially Equivalent | |
| K043250 | STRYKER PATIENT SPECIFIC POLYMER IMPLANT | KKY | Substantially Equivalent | |
| K041651 | STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM | DZE | Substantially Equivalent | |
| K040022 | STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM | HRS | Substantially Equivalent | |
| K022579 | STRYKER NAVIGATION SYSTEM-KNEE MODULE | HAW | Substantially Equivalent | |
| K023449 | NON-INVASIVE PATIENT FIXATION SYSTEM | IYE | Substantially Equivalent | |
| K013775 | TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM | HRS | Substantially Equivalent | |
| K012380 | MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY | HAW | Substantially Equivalent | |
| K000594 | LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE | JEY | Substantially Equivalent | |
| K000349 | MOTORIZED MICRO MULTILEAF COLLIMATOR | IXI | Substantially Equivalent | |
| K000348 | COLORADO MICRODISSECTION NEEDLE | GEI | Substantially Equivalent | |
| K991398 | BONESOURCE HYDROXYAPATITE CEMENT (HAC) EXPANDED KIT | GXP | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- IYEAccelerator, Linear, Medical
- IXIBlock, Beam-Shaping, Radiation Therapy
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- DZEImplant, Endosseous, Root-Form
- KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- GXPMethyl Methacrylate For Cranioplasty
- HAWNeurological Stereotaxic Instrument
- JEYPlate, Bone
- GXNPlate, Cranioplasty, Preformed, Non-Alterable
- HRSPlate, Fixation, Bone
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain