FDA.reportPublic FDA data

AMPLITUDE

Primary DI
03701089527712
Brand
AMPLITUDE
Company
AMPLITUDE SAS
Model
2-0255103
Catalog number
2-0255103
Device description
4-in1 Cutting Block Size 3
Published
2026-07-29
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

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTZINSTRUMENT, CUTTING, ORTHOPEDIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701089527712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701089527712037010895277123701089527712

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning 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 [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Contacts#

Phone, Email table
PhoneEmail
+0033475418741regulatoryaffairs@amplitude-ortho.com

Regulatory Flags#

DUNS number
634855407
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03701089515153AMPLITUDE2-01024002-01024002026-07-29
03701089517492TRAX1-02084001-02084002026-07-29
03701089517508TRAX1-02084011-02084012026-07-29
03701089517515TRAX1-02084021-02084022026-07-29
03701089517522TRAX1-02084031-02084032026-07-29
03701089517539TRAX1-02084041-02084042026-07-29
03701089517546TRAX1-02084051-02084052026-07-29
03701089517553TRAX1-02084061-02084062026-07-29
03701089517560TRAX1-02084071-02084072026-07-29
03701089517577TRAX1-02084081-02084082026-07-29
03701089517584TRAX1-02085001-02085002026-07-29
03701089517591TRAX1-02085011-02085012026-07-29
03701089517607TRAX1-02085021-02085022026-07-29
03701089517614TRAX1-02085031-02085032026-07-29
03701089517621TRAX1-02085041-02085042026-07-29
03701089517638TRAX1-02085051-02085052026-07-29
03701089517645TRAX1-02085061-02085062026-07-29
03701089517652TRAX1-02085071-02085072026-07-29
03701089517669TRAX1-02085081-02085082026-07-29
03701089518390TRAX1-02089001-02089002026-07-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701089527491AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527507AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527514AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527521AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527583AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527590AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527606AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527682AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527699AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527705AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527729AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527736AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527743AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527750AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527767AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527774AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527781AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527798AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527804AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527811AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527828AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527835AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527842AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089527859AMPLITUDEAMPLITUDE SASHTZ2026-07-29
03701089540780AMPLITUDEAMPLITUDE SASHTZ2026-07-29
00190776402129MillenniumAvalign Technologies, Inc.HTZ2026-07-19
M697X07901151Silex Sacroiliac Joint Fusion SystemXtant Medical Holdings, Inc.HTZ2026-07-08
10603295552390ATTUNEDEPUY ORTHOPAEDICS, INC.HTZ2026-05-18
07649988948701SPIRECUTSPIRECUT SAHTZ2026-05-04
07649988948718SPIRECUTSPIRECUT SAHTZ2026-05-04