FDA.reportPublic FDA data

SternaFuse® Fixation System

Primary DI
00810047770046
Brand
SternaFuse® Fixation System
Company
Fusion Innovations LLC
Model
76-3010-4
Device description
Locking Screw 4-PackØ3.0mm X 10mm, Cancellous, Self-Drilling
Published
2022-12-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202914000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202914000SternaFuse Fixation SystemFusion Innovations, LLC2022-01-26HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810047770046PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810047770046008100477700468100477700460810047770046

GMDN Terms#

Term, Definition table
TermDefinition
Sternal fixation deviceA collection of devices intended to be used for primary or secondary closure/repair of the sternum, typically following sternotomy or fracture of the sternum, to stabilize the sternum and promote fusion. The sternal fixation system (SFS) typically consist of titanium (Ti) or high-grade stainless steel plates, pins, cables, and locking screws, which are used to selectively create the device construct by the surgeon. This is a single-patient device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length10Millimeter
Outer Diameter3Millimeter

Contacts#

Phone, Email table
PhoneEmail
1-888-316-7627info@sternafuse.com

Regulatory Flags#

DUNS number
024495683
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810047770015SternaFuse® Fixation System76-3010-22022-12-14
00810047770022SternaFuse® Fixation System76-3013-22022-12-14
00810047770039SternaFuse® Fixation System76-3016-22022-12-14
00810047770053SternaFuse® Fixation System76-3013-42022-12-14
00810047770060SternaFuse® Fixation System76-3016-42022-12-14
00810047770077SternaFuse® Fixation System76-3010-62022-12-14
00810047770084SternaFuse® Fixation System76-3013-62022-12-14
00810047770091SternaFuse® Fixation System76-3016-62022-12-14
00810047770107SternaFuse® Fixation System76-3310-22022-12-14
00810047770114SternaFuse® Fixation System76-3313-22022-12-14
00810047770121SternaFuse® Fixation System76-3316-22022-12-14
00810047770145SternaFuse® Fixation System76-10032022-12-14
00810047770169SternaFuse® Fixation System76-10072022-12-14
00810047770176SternaFuse® Fixation System76-10132022-12-14
00810047770190SternaFuse® Fixation System76-20012022-12-14
00810047770220SternaFuse® Fixation System76-15052022-12-14
00810047770237SternaFuse® Fixation System76-15062022-12-14
00810047770244SternaFuse® Fixation System76-15082022-12-14
00810047770251SternaFuse® Fixation System76-15092022-12-14
00810047770275SternaFuse® Fixation System76-25062022-12-14

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Primary DI, Brand, Company table
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00196449002610LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002627LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
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00196449002641LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
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00196449002771LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002788LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002795LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002801LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08