FDA.reportPublic FDA data

NA

Primary DI
10705034560465
Brand
NA
Company
Medos International Sàrl
Model
286005346N
Catalog number
286005346N
Device description
Angled Ring Curette Navigated 6mm
Published
2022-08-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212756000
K233254000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212756000Discectomy Navigation Ready Instruments and Universal Navigation Adaptor SetMedos International SARL2022-05-05OLO
K233254000TELIGEN System Navigation Ready InstrumentsDePuy Synthes2024-06-14OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10705034560465PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1070503456046510705034560465

GMDN Terms#

Term, Definition table
TermDefinition
Bone curette, reusableA manual surgical instrument designed for cutting and excising bone tissue typically during an orthopaedic or a plastic surgery procedure. It is typically designed as a long, slender instrument with a handle at the proximal end and a concave, spoon-like tip which has a sharp edge, at the distal end, or it may be double-ended, and is used to facilitate the removal of the bone tissue without causing trauma to the surrounding muscles. It is typically made of high-grade stainless steel and is a common instrument of choice for the removal of the bone. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
482661753
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10705034579689N/A6983451876983451872026-09-26
10705034579696N/A6983451886983451882026-09-26
10705034579702N/A6983451896983451892026-09-26
10705034581835ROBOTIC INTEGRATION INSTRUMENTS2914-89-0012914890012025-04-17
10705034581842ROBOTIC INTEGRATION INSTRUMENTS2914-89-0022914890022025-04-17
10705034602349ROBOTIC INTEGRATION INSTRUMENTS2914-89-4032914894032025-04-17
10705034602424ROBOTIC INTEGRATION INSTRUMENTS2914-89-4012914894012025-04-17
10705034602462ROBOTIC INTEGRATION INSTRUMENTS2914-89-0002914890002025-04-17
10705034643243VELYS4516110384516110382025-03-28
10705034643250VELYS4516110504516110502025-03-28
10705034643274VELYS4516110214516110212025-03-28
10705034643281VELYS4516110554516110552025-03-28
10705034643298VELYS4516110474516110472025-03-28
10705034643304VELYS4516110464516110462025-03-28
10705034643328VELYS4516110404516110402025-03-28
10705034643342VELYS4516110624516110622025-03-28
10705034643359VELYS4516110454516110452025-03-28
10705034643366VELYS4516110444516110442025-03-28
10705034643373VELYS4516110434516110432025-03-28
10705034643380VELYS4516110414516110412025-03-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810131884079TiLink-L Rescue Impact CapSurgentec, LLCOLO2026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSurgentec, LLCOLO2026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOLO2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOLO2026-09-25
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