FDA.report

Seeker-Fulcrum

Primary DI
00810111220163
Brand
Seeker-Fulcrum
Company
TREACE MEDICAL CONCEPTS, INC.
Model
1405-2482
Device description
Seeker Fulcrum - Left
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
00810111220163PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810111220163008101112201638101112201630810111220163

GMDN Terms

TermDefinition
Bone lever/elevator, reusableA manual surgical instrument designed to lift, position, or pry up (elevate) bone, other anatomical structures, or surgical material/devices during an orthopaedic intervention. It is made of high-grade stainless steel and is available in a wide variety of sizes, designs, and blade shapes. It is typically a robust instrument with a blunted blade with no cutting edge at the distal end that can be pointed, rounded, flat, curved or hook shaped and a handle of various designs at the proximal end. Some types can have special functions, e.g., for angle joint operations or for luxation procedures. This is a reusable device.

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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