Stryker Spine: FDA filings under this applicant name

FDA lists 75 510(k) clearances under the applicant name “Stryker Spine” (first 2004, latest 2026), plus 1 PMA decision, across 17 product codes in 3 review panels. Median 510(k) review time under this name: 72 days. Since 2017 the median was 91 days, against 91 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Stryker Spine took a median 91 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 91 days.

Top product codes

Plus 7 more product codes.

Review panels

• Orthopedic (74)
• Neurology (1)
• General and Plastic Surgery (1)

Most recent Stryker Spine 510(k) clearances

65 earlier clearances. See the full list in Caduvo.

PMA and De Novo decisions

Recalls

99 product recalls in 42 recall events; 6 initiated in the last five years. Most recent: 2025-02-28.

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 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)
• Stryker Corporate (6 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Stryker Spine?

FDA lists 75 510(k) clearances under the applicant name “Stryker Spine” (first 2004, latest 2026), plus 1 PMA decision, across 17 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 Spine?

The median time from FDA receipt to decision across 510(k)s cleared under the name Stryker Spine is 72 days. Since 2017: 91 days, versus 91 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Stryker Spine?

The most frequent FDA product codes under this applicant name are NKB (Thoracolumbosacral Pedicle Screw System, 22); MQP (Spinal Vertebral Body Replacement Device, 8); KWP (Appliance, Fixation, Spinal Interlaminal, 7).

Next steps

• See all 75 Stryker Spine clearances with predicates and recalls
• Run predicate analysis for product code NKB, Stryker Spine'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.

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