SUBFIX SUT0065

GUDID 07613252263494

Arthroeresis Implant

Stryker Trauma SA

Orthopaedic bone staple, non-adjustable, non-sterile Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable Orthopaedic bone staple, non-adjustable

Primary Device ID	07613252263494
NIH Device Record Key	58d1fe71-3c61-46f4-be88-e8dd22d21988
Commercial Distribution Status	In Commercial Distribution
Brand Name	SUBFIX
Version Model Number	SUT0065
Catalog Number	SUT0065
Company DUNS	481999654
Company Name	Stryker Trauma SA
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

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Device Identifiers

Device Issuing Agency	Device ID
GS1	07613252263494 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K093820

FDA Product Code

HWC	Screw, fixation, bone