FDA.reportPublic FDA data

Orientable Alignment Guide - Lateral 20°/45°

Primary DI
07630055303042
Brand
Orientable Alignment Guide - Lateral 20°/45°
Company
Incipio Devices SA
Model
50340170
Device description
Alignment guide accessory of Offset Cup Impactor
Published
2021-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HWAImpactor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWAImpactorOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630055303042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630055303042076300553030427630055303042

GMDN Terms#

Term, Definition table
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 table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
485098284
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630055307026Offset Reamer Handle - Large AO - Tri coupling922061T502445112026-05-07
07630055307033Offset reamer handle - Tri Coupling Transmission922061T-EZ502445102026-05-07
07630055307736ACE Acetabular Reamer Tray - Instrument Tray50740101507401012026-04-30
07630055306722Offset reamer handle - Dual Coupling90CH.IN.004502445002026-03-17
07630055306739Offset reamer handle - Large AO motor shaft90CH.IN.AO1502445062026-03-17
07630055306746Offset reamer handle - Stryker Z/H motor shaft90CH.IN.ZH1502445072026-03-17
07630055306753Offset reamer handle - Hudson motor shaft90CH.IN.HU1502445082026-03-17
07630055306760Straight reamer handle - large AO - Dual coupling90ST.IN.AO1502445502026-03-17
07630055306777Straight reamer handle -Stryker Z/H - Dual coupling90ST.IN.ZH1502445512026-03-17
07630055306784Straight reamer handle - Hudson - Dual coupling90ST.IN.HU1502445522026-03-17
07630055306791Offset reamer handle - Dual coupling131-174/05502445002026-03-10
07630055306807Offset reamer handle - Handle131-174/01502445042026-03-10
07630055306814Offset reamer handle - Body131-174/02502445052026-03-10
07630055306821Offset reamer handle - Dual Coupling transmission131-174/03502445092026-03-10
07630055306838Offset reamer handle - Large AO motor shaft131-174/04D502445062026-03-10
07630055306845Offset reamer handle - Stryker Z/H motor shaft131-174/04H502445072026-03-10
07630055306852Offset reamer handle - Hudson motor shaft131-174/04B502445082026-03-10
07630055306869Straight reamer handle - Jacobs - Dual coupling131-171E502445492026-03-10
07630055306876Straight reamer handle - large AO - Dual coupling131-171D502445502026-03-10
07630055306883Straight reamer handle -Stryker Z/H - Dual coupling131-171H502445512026-03-10

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