FDA.report

Tritium® Sternal Cable Plate System

Primary DI
00846468050009
Brand
Tritium® Sternal Cable Plate System
Company
Pioneer Surgical Technology, Inc.
Model
86-30-10-4
Catalog number
86-30-10-4
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

Related Records

Contact Domains

Product Codes

CodeName
HRSPlate, fixation, bone

Product Code Classifications

CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00846468050009PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00846468050009008464680500098464680500090846468050009

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

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

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00840298701988CODA™ Anterior Cervical Plate System58-2022010262022-01-0262023-01-19
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