FDA.reportPublic FDA data

Tritium® Sternal Cable Plate System

Primary DI
00846468078140
Brand
Tritium® Sternal Cable Plate System
Company
Pioneer Surgical Technology, Inc.
Model
86-350-S
Catalog number
86-350-S
Device description
4 Hole Double Cable Plate, Sharp Needle
Published
2016-09-23
Public version status
Update
Distribution status
Not 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
HWCScrew, fixation, bone
JDQCERCLAGE, FIXATION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
JDQCerclage, FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K161876000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K161876000Tritium® Sternal Cable Plate SystemPioneer Surgical Technology, Inc., Dba Rti Surgical, Inc.2016-09-09JDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00846468078140PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468078140008464680781408464680781400846468078140

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

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
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840298703685CODA™ Anterior Cervical Plate System58-202230010S2022-30-010S2023-06-28
00840298703708CODA™ Anterior Cervical Plate System58-202230014S2022-30-014S2023-06-28
00840298701445CODA™ Anterior Cervical Plate System58-102201010S1022-01-010S2023-06-26
00840298701452CODA™ Anterior Cervical Plate System58-102201012S1022-01-012S2023-06-26
00840298701469CODA™ Anterior Cervical Plate System58-102201014S1022-01-014S2023-06-26
00840298701476CODA™ Anterior Cervical Plate System58-102201016S1022-01-016S2023-06-26
00840298701490CODA™ Anterior Cervical Plate System58-102201020S1022-01-020S2023-06-26
00840298701506CODA™ Anterior Cervical Plate System58-102201022S1022-01-022S2023-06-26
00840298701520CODA™ Anterior Cervical Plate System58-102201026S1022-01-026S2023-06-26
00840298701537CODA™ Anterior Cervical Plate System58-102201028S1022-01-028S2023-06-26
00840298701544CODA™ Anterior Cervical Plate System58-102201030S1022-01-030S2023-06-26
00840298701568CODA™ Anterior Cervical Plate System58-102202026S1022-02-026S2023-06-26
00840298701582CODA™ Anterior Cervical Plate System58-102202030S1022-02-030S2023-06-26
00840298701599CODA™ Anterior Cervical Plate System58-102202032S1022-02-032S2023-06-26
00840298701605CODA™ Anterior Cervical Plate System58-102202034S1022-02-034S2023-06-26
00840298701612CODA™ Anterior Cervical Plate System58-102202036S1022-02-036S2023-06-26
00840298701629CODA™ Anterior Cervical Plate System58-102202038S1022-02-038S2023-06-26
00840298701636CODA™ Anterior Cervical Plate System58-102202040S1022-02-040S2023-06-26
00840298701643CODA™ Anterior Cervical Plate System58-102202042S1022-02-042S2023-06-26
00840298701650CODA™ Anterior Cervical Plate System58-102202044S1022-02-044S2023-06-26

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Primary DI, Brand, Company table
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