FDA.reportPublic FDA data

Tritium® Sternal Cable Plate System

Primary DI
00846468050023
Brand
Tritium® Sternal Cable Plate System
Company
Pioneer Surgical Technology, Inc.
Model
86-30-14-4
Catalog number
86-30-14-4
Device description
RESCUE SCREW 4-PACK
Published
2016-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDQCERCLAGE, FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDQCerclage, FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846468050023PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468050023008464680500238464680500230846468050023

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(906)226-9909labeling@resolvesurg.com
+1(906)226-9909regulatory@exalta.com

Regulatory Flags#

DUNS number
793384496
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840298701902CODA™ Anterior Cervical Plate System58-2022010102022-01-0102023-01-19
00840298701971CODA™ Anterior Cervical Plate System58-2022010242022-01-0242023-01-19
00840298702039CODA™ Anterior Cervical Plate System58-2022020282022-02-0282023-01-19
00840298702268CODA™ Anterior Cervical Plate System58-2022040802022-04-0802023-01-19
00840298700134CODA™ Anterior Cervical Plate System58-202221018S2022-21-018S2023-01-19
00840298700028CODA™ Anterior Cervical Plate System58-202220014S2022-20-014S2023-01-19
00840298700110CODA™ Anterior Cervical Plate System58-202221014S2022-21-014S2023-01-19
00840298700677CODA™ Anterior Cervical Plate System58-2022302002022-30-2002023-01-24
00840298701957CODA™ Anterior Cervical Plate System58-2022010202022-01-0202023-01-19
00840298702022CODA™ Anterior Cervical Plate System58-2022020262022-02-0262023-01-19
00840298702251CODA™ Anterior Cervical Plate System58-2022040762022-04-0762023-01-19
00840298700608CODA™ Anterior Cervical Plate System58-2022222002022-22-2002023-01-24
00840298700776CODA™ Anterior Cervical Plate System58-2022100072022-10-0072023-01-25
00840298700905CODA™ Anterior Cervical Plate System58-2022207172022-20-7172023-01-19
00840298701933CODA™ Anterior Cervical Plate System58-2022010162022-01-0162023-01-19
00840298701988CODA™ Anterior Cervical Plate System58-2022010262022-01-0262023-01-19
00840298702091CODA™ Anterior Cervical Plate System58-2022020402022-02-0402023-01-19
00840298702114CODA™ Anterior Cervical Plate System58-2022020442022-02-0442023-01-19
00840298702138CODA™ Anterior Cervical Plate System58-2022030452022-03-0452023-01-19
00840298702176CODA™ Anterior Cervical Plate System58-2022030572022-03-0572023-01-19

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Primary DI, Brand, Company table
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07899258696942Stitch Cerclage - Suture TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-08-25
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07899258696966Stitch Cerclage - Suture TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-08-25
07899258696973Stitch Cerclage - Suture TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-08-25
07899258696980Stitch Cerclage - Suture TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-08-25
07899258696997Stitch Cerclage - Suture TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-08-25
07899258697000Stitch Cerclage - Suture TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-08-25
07899258697017Stitch Cerclage - Suture TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-08-25
07899258697024Stitch Cerclage - Suture TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-08-25
07899258697031Stitch Cerclage - Suture TapesGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-08-25
00888867504561Arthrex®ARTHREX, INC.JDQ2025-06-17
00888867504585Arthrex®ARTHREX, INC.JDQ2025-06-17
00888867516717Arthrex®ARTHREX, INC.JDQ2025-05-16
00888867516724Arthrex®ARTHREX, INC.JDQ2025-05-16
00888867516748Arthrex®ARTHREX, INC.JDQ2025-05-16
07899258636658Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-04-25
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07899258654706Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2025-04-25
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10841291105824Sternal Cable SystemA & E MEDICAL CORPORATIONJDQ2025-04-21
10841291105831Sternal Cable SystemA & E MEDICAL CORPORATIONJDQ2025-04-21
10841291105855Sternal Cable SystemA & E MEDICAL CORPORATIONJDQ2025-04-21
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10841291105930Sternal Cable SystemA & E MEDICAL CORPORATIONJDQ2025-04-21
10841291105947Sternal Cable SystemA & E MEDICAL CORPORATIONJDQ2025-04-21