FDA.reportPublic FDA data

SternaFuse® Fixation System

Primary DI
00810047770602
Brand
SternaFuse® Fixation System
Company
Fusion Innovations LLC
Model
76-9008
Device description
Disposable Driver BitAO Connection, Standard
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
00810047770602PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810047770602008100477706028100477706020810047770602

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.

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
00810047770046SternaFuse® Fixation System76-3010-42022-12-14
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842188131615CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131639CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131653CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131677CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131721CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00889095401820ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401844ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401868ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401882ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401905ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401929ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402285ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402438ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402483ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402537ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411263ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411287ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411300ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411324ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095611274ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
10886982342508VOLTSynthes GmbHHWC2026-09-25
10886982342515VOLTSynthes GmbHHWC2026-09-25
10886982342522VOLTSynthes GmbHHWC2026-09-25
10886982342539VOLTSynthes GmbHHWC2026-09-25
10886982342546VOLTSynthes GmbHHWC2026-09-25
10886982342553VOLTSynthes GmbHHWC2026-09-25
10886982342560VOLTSynthes GmbHHWC2026-09-25
10886982342577VOLTSynthes GmbHHWC2026-09-25
10886982342584VOLTSynthes GmbHHWC2026-09-25
10886982342591VOLTSynthes GmbHHWC2026-09-25