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Medical device manufacturer

Stryker Corporation

Stryker Corporation holds 352 FDA 510(k) clearances across 106 product codes. Median elapsed review time is 97 days. openFDA lists 192 recall records naming the company. FDA publishes it under 12 different spellings, all counted here as one company.

Updated · ingest status · JSON

510(k) clearances
352
Product codes
106
Median review
97 days
Recall records
192

How does FDA spell Stryker Corporation?

FDA publishes this company under 12 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Every spelling FDA published for this company, and which dataset each came from.
As FDA published itDatasetMatched by
STRYKER CORP.device/registrationlistingnormalised
STRYKER GmbHdevice/registrationlistingnormalised
Strykerdevice/510knormalised
Stryker Corp.device/510knormalised
Stryker Corporationdevice/recallnormalised
Stryker Corporationdevice/enforcementnormalised
Stryker Corporationdevice/510knormalised
Stryker GmbHdevice/enforcementnormalised

Showing 8 of 12.

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Stryker Corporation file in?

106 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
CodeDeviceClearancesMedian reviewLatest
HRSPlate, Fixation, Bone25109 days
GCJLaparoscope, General & Plastic Surgery2043 days
MAXIntervertebral Fusion Device With Bone Graft, Lumbar1779 days
JEYPlate, Bone13134 days
HRXArthroscope1284 days
HSBRod, Fixation, Intramedullary And Accessories1290 days
KTTAppliance, Fixation, Nail/Blade/Plate Combination, Multiple Component1191 days
GWOPlate, Cranioplasty, Preformed, Alterable10125 days
MBIFastener, Fixation, Nondegradable, Soft Tissue1090 days
NKBThoracolumbosacral Pedicle Screw System1056 days
GEIElectrosurgical, Cutting & Coagulation & Accessories9135 days
OLOOrthopedic Stereotaxic Instrument9108 days
ERLDrill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece887 days
HAWNeurological Stereotaxic Instrument8126 days
HBEDrills, Burrs, Trephines & Accessories (Simple, Powered)7141 days
KWQAppliance, Fixation, Spinal Intervertebral Body7119 days
NDNCement, Bone, Vertebroplasty7104 days
HWCScrew, Fixation, Bone6104 days
OWNConfocal Optical Imaging626 days
FNLBed, Ac-Powered Adjustable Hospital566 days
KNWInstrument, Biopsy573 days
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented5126 days
FYAGown, Surgical4120 days
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar484 days
DQYCatheter, Percutaneous389 days

Showing the 25 they file in most, of 106.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved

Has Stryker Corporation had a recall?

openFDA lists 192 recall records naming this company across its whole history, of which 18 were opened in the last 12 months and are not yet marked terminated. A recall record covers one firm's corrective action and may span many device lots.

  • Z-2827-2026Open, ClassifiedKTT

    Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

  • Z-2828-2026Open, ClassifiedKTT

    Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

  • Z-2829-2026Open, ClassifiedKTT

    Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

  • Z-2830-2026Open, ClassifiedKTT

    Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

  • Z-2831-2026Open, ClassifiedKTT

    Potential cracking of the Hoffmann II Carbon Connecting Rods following cleaning and sterilization.

Showing the 5 most recently initiated of 192.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved

What has Stryker Corporation cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)DeviceCodeDecisionElapsed days
K261481Pangea Femur Reconstruction SystemHSB55
K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemHSB76
K253202Hoffmann LRF SystemKTT84
K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemHSB106
K250163T2 Alpha Femur Retrograde Nailing SystemHSB204
K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea Tibia Plating SystemHRS51
K233919VariAx 2 Distal Radius SystemHRS103
K233741Hoffmann LRF SystemKTT29
K230045HipCheckQIH266
K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMOWN89

Source: openFDA device/510k · retrieved

Where is Stryker Corporation registered?

FDA lists 2 registered establishments for this company in US.

Registration means the firm has told FDA it makes or distributes devices from that site. It is not a clearance, an approval or an endorsement.

Watch what Stryker Corporation files next

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.