FDA.report

Positioner

Primary DI
00853114006600
Brand
Positioner
Company
TREACE MEDICAL CONCEPTS, INC.
Model
1405-2196
Device description
Positioner
Published
2022-09-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00853114006600PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00853114006600008531140066008531140066000853114006600

GMDN Terms

TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
054808082
Device count
1
DM exempt
false
Premarket exempt
true
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 DIBrandModelCatalogPublished
00810111225489Instrument Tray02-004622026-03-23
00810111226745Instrument Tray02-005212026-03-23
00810111227148K-Wire02-004732026-03-23
00810111225649Depth Gage02-004502026-03-19
00810111225601Reamer02-004192026-03-02
00810111225618Reamer02-004182026-03-02
00810111225625Reamer02-004172026-03-02
00810111226691Positioner / Compressor02-005152026-02-20
00810111225366Saw BladeSN442026-01-26
00810111225236Lapiplasty SpeedPlate - TMTSK682026-01-23
00810111225397Guide02-004232026-01-23
00810111225403Guide02-004222026-01-23
00810111225472Drill Guide02-004802026-01-23
00810111225342Saw Blade02-003682026-01-07
00810111226677Positioner / Compressor02-005132026-01-05
00810111226684Positioner / Compressor02-005142026-01-05
00810111226707Positioner / Compressor02-005162026-01-05
00810111225335Saw Blade02-003672025-12-18
00810111224918TMC FastPitch ScrewsSD312025-12-12
00810111225175TMC SpeedTMT02-004022025-12-12

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