FDA.reportPublic FDA data

Olive Wire

Primary DI
00810111221139
Brand
Olive Wire
Company
Treace Medical Concepts, Inc.
Model
1405-2376
Device description
Olive wire with thread
Published
2022-09-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810111221139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810111221139008101112211398101112211390810111221139

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
054808082
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810111227353ScalpelSN562026-06-05
00810111227292K-Wire02-005432026-06-02
00810111227346Scalpel 02-003872026-05-19
00810111227223SpeedMTP SelectSK692026-05-13
00810111227247SpeedMTP SelectSD342026-05-13
00810111227254SpeedMTP SelectSD332026-05-13
00810111225663X-ray App12-000012026-05-01
00810111226769ReamerSN502026-05-01
00810111226776ReamerSN512026-05-01
00810111226783ReamerSN522026-05-01
00810111227261K-Wire02-005202026-04-27
00810111224987Screwdriver02-004402026-04-15
00810111225007Screwdriver02-004422026-04-15
00810111225021Screwdriver02-004442026-04-15
00810111225069Screwdriver02-004482026-04-15
00810111225458Instrument Tray02-004822026-04-15
00810111225670Screwdriver02-005062026-04-15
00810111225687Percuplasty SuperBite Compression ScrewSC701302026-04-15
00810111225694Percuplasty SuperBite Compression ScrewSC701252026-04-15
00810111225700Percuplasty SuperBite Compression ScrewSC701202026-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842078125724CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078125748CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130261CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130315CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130452CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130490CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078130537CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134054CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134061CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134078CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134085CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134092CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134108CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134115CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00850078396303PFT Adapter, SYK, Virata, 85 in-lb (228-TXRX-006)Eca Medical InstrumentsHWE2026-06-05
00850078396310PFT Adapter, SYK, Mariner, 105 in-lb (228-TXRX-007)Eca Medical InstrumentsHWE2026-06-05
10705034647807TRIALTISMedos International SàrlHWE2026-06-03
10705034647814TRIALTISMedos International SàrlHWE2026-06-03
10705034647821TRIALTISMedos International SàrlHWE2026-06-03
10705034647838TRIALTISMedos International SàrlHWE2026-06-03
10705034648118TRIALTISMedos International SàrlHWE2026-06-03
00810111227292K-WireTreace Medical Concepts, Inc.HWE2026-06-02
07613327648331PANGEAStryker GmbHHWE2026-06-02
07613327648362PANGEAStryker GmbHHWE2026-06-02
07613327652703N/ASTRYKER CORPORATIONHWE2026-04-15
07613327652710PROstepSTRYKER CORPORATIONHWE2026-04-13
07613327652727N/ASTRYKER CORPORATIONHWE2026-04-13
07613327652734N/ASTRYKER CORPORATIONHWE2026-04-13
07613327652741N/ASTRYKER CORPORATIONHWE2026-03-25
07613327652758N/ASTRYKER CORPORATIONHWE2026-03-25