Stryker Leibinger: FDA clearances and approvals
Stryker Leibinger has 13 FDA 510(k) clearances (first 1999, latest 2014), across 10 product codes in 5 review panels. Median 510(k) review time: 90 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 88 |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | 3 | 3 |
| HAW | Neurological Stereotaxic Instrument | 2 | 2 |
| DZE | Implant, Endosseous, Root-Form | 1 | 1 |
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 1 | 1 |
| GXN | Plate, Cranioplasty, Preformed, Non-Alterable | 1 | 1 |
| GXP | Methyl Methacrylate For Cranioplasty | 1 | 1 |
| IXI | Block, Beam-Shaping, Radiation Therapy | 1 | 1 |
| IYE | Accelerator, Linear, Medical | 1 | 1 |
| JEY | Plate, Bone | 1 | 1 |
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 1 | 1 |
Review panels
- Neurology (4)
- Orthopedic (3)
- Dental (2)
- Radiology (2)
- General and Plastic Surgery (2)
Most recent Stryker Leibinger 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K133974 | VARIAX DISTAL RADIUS PLATING SYSTEM | HRS | 2014-03-24 | 88 |
| K052871 | STRYKER CUSTOM TI IMPLANT | GXN | 2005-12-16 | 66 |
| K043250 | STRYKER PATIENT SPECIFIC POLYMER IMPLANT | KKY | 2005-04-15 | 143 |
| K041651 | STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM | DZE | 2004-09-30 | 105 |
| K040022 | STRYKER LEIBINGER UNIVERSAL DISTAL RADIUS SYSTEM | HRS | 2004-03-12 | 65 |
| K022579 | STRYKER NAVIGATION SYSTEM-KNEE MODULE | HAW | 2003-06-02 | 301 |
| K023449 | NON-INVASIVE PATIENT FIXATION SYSTEM | IYE | 2003-01-13 | 90 |
| K013775 | TWINFIX INTERFRAGMENTARY COMPRESSION SCREW SYSTEM | HRS | 2002-01-08 | 56 |
| K012380 | MODIFICATION TO: STRYKER NAVIGATION SYSTEM, STRYKER FLUOROSCOPY SYSTEM,VIRTUAL FLUOROSCOPY | HAW | 2001-12-03 | 130 |
| K000594 | LOCKING SCREW MANDIBULAR RECONSTRUCTION PLATE | JEY | 2000-12-08 | 290 |
3 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Stryker Leibinger.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Stryker Leibinger have?
Stryker Leibinger has 13 FDA 510(k) clearances (first 1999, latest 2014), across 10 product codes in 5 review panels.
How long does FDA take to clear Stryker Leibinger's 510(k)s?
The median time from FDA receipt to decision across Stryker Leibinger's cleared 510(k)s is 90 days.
What devices does Stryker Leibinger make?
Its most frequent FDA product codes are HRS (Plate, Fixation, Bone, 3); HAW (Neurological Stereotaxic Instrument, 2); DZE (Implant, Endosseous, Root-Form, 1).
Has Stryker Leibinger had device recalls?
openFDA lists no recalls under a recalling firm name matching Stryker Leibinger. Related entities may recall under other names.
Next steps
- See all 13 Stryker Leibinger clearances with predicates and recalls
- Run predicate analysis for product code HRS, Stryker Leibinger's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.