Stryker Corporate: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Stryker Corporate” (first 2013, latest 2016), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 177 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Stryker, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2013 | 2 | 177 |
| 2014 | 2 | 98 |
| 2015 | 1 | 260 |
| 2016 | 1 | 241 |
| 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 |
|---|---|---|---|
| OLO | Orthopedic Stereotaxic Instrument | 3 | 3 |
| HAW | Neurological Stereotaxic Instrument | 2 | 2 |
| PGW | Ear, Nose, And Throat Stereotaxic Instrument | 1 | 1 |
Review panels
- Orthopedic (3)
- Neurology (2)
- Ear, Nose and Throat (1)
Most recent Stryker Corporate 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K153240 | Styrker OrthoMap Express Knee System | OLO | 2016-07-07 | 241 |
| K143597 | Navigated XIA 4.5 Polyaxial Screwdriver | OLO | 2015-09-04 | 260 |
| K141941 | SPINEMASK TRACKER, SPINEMAP 3D 3.0-SOFTWARE,SPINEMAP 3D 3.0-UPGREADE, SPINEMAP 3D 3.0-ENABLE, SPINEMAP 3D 3.0-SALES D | OLO | 2014-10-31 | 106 |
| K141551 | PROFESS SOFTWARE, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 70 (DEGREES) SUCTION, PROFESS CURVED 90 (DEGREES) | PGW | 2014-09-08 | 89 |
| K131214 | CRANIAL MAP NEURO | HAW | 2013-10-18 | 172 |
| K130874 | STRYKER NAV3I PLATFORM | HAW | 2013-09-27 | 182 |
Recalls
openFDA lists no recalls under a recalling firm named Stryker Corporate.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Stryker Corp. (352 510(k)s)
- Stryker Endoscopy (102 510(k)s)
- Stryker Spine (75 510(k)s)
- Stryker Instruments (75 510(k)s)
- Stryker Sustainability Solutions (34 510(k)s)
- Stryker Neurovascular (33 510(k)s)
- Stryker Trauma AG (25 510(k)s)
- Stryker Orthopaedics (24 510(k)s)
- Stryker Leibinger GmbH & Co KG (22 510(k)s)
- Stryker Medical (14 510(k)s)
- Stryker Leibinger (13 510(k)s)
- Stryker Trauma GmbH (7 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Stryker Corporate?
FDA lists 6 510(k) clearances under the applicant name “Stryker Corporate” (first 2013, latest 2016), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Stryker Corporate?
The median time from FDA receipt to decision across 510(k)s cleared under the name Stryker Corporate is 177 days.
Which FDA product codes appear under Stryker Corporate?
The most frequent FDA product codes under this applicant name are OLO (Orthopedic Stereotaxic Instrument, 3); HAW (Neurological Stereotaxic Instrument, 2); PGW (Ear, Nose, And Throat Stereotaxic Instrument, 1).
Next steps
- See all 6 Stryker Corporate clearances with predicates and recalls
- Run predicate analysis for product code OLO, Stryker Corporate's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.