FDA.reportPublic FDA data

SternaFuse® Fixation System

Primary DI
00810047770251
Brand
SternaFuse® Fixation System
Company
Fusion Innovations LLC
Model
76-1509
Device description
Hex Plate6 Holes
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
HRSPlate, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, 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
00810047770251PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810047770251008100477702518100477702510810047770251

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
00810047770275SternaFuse® Fixation System76-25062022-12-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008405368000393P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000463P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000533P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
008405368000603P Hip SystemORTHOPEDIATRICS CORP.HRS2026-06-09
08809986479938CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
08809986479945CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-06-08
00370056966385Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658151Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658175Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658199Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569662202Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663247Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663841Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663865Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663872Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663889Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663896Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663902Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663919Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663926Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663933Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663940Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663964Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569671327Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676438Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676445Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676452Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676469Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
00850080543009PC Fix Locking Post TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543016PC Fix Locking Cap TiChest Wall Innovations, Inc.HRS2026-06-01