FDA.reportPublic FDA data

AMPLITUDE

Primary DI
03701089543378
Brand
AMPLITUDE
Company
AMPLITUDE SAS
Model
2-0237700
Catalog number
2-0237700
Device description
4T Tibial resection guide right - 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
FZXGuide, surgical, instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701089543378PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701089543378037010895433783701089543378

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
00190376544496InvictusALPHATEC SPINE, INC.FZX2026-07-30
03701089528054AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089542548AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543316AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543330AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543354AMPLITUDEAMPLITUDE SASFZX2026-07-29
03701089543682AMPLITUDEAMPLITUDE SASFZX2026-07-29
03700569674335Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-28
03700569674342Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-28
03700569674281Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-27
03700569674298Newclip InstrumentsNEWCLIP TECHNICSFZX2026-07-27
00842188132568Tools-AFSTrimed, INC.FZX2026-07-24
00841731153128ARTEMIS FUZEVILEX LLCFZX2026-07-22
00888118147226LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147233LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147240LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147257LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147264LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147271LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147714LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147721LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147738LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147745LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00810111228374Positioner / CompressorTreace Medical Concepts, Inc.FZX2026-07-17
00810111228381Positioner / CompressorTreace Medical Concepts, Inc.FZX2026-07-17
18257200131198Firebird SI FusionOrthofix US LLCFZX2026-07-17
18257200131204Firebird SI FusionOrthofix US LLCFZX2026-07-17
18257200131235Firebird SI FusionOrthofix US LLCFZX2026-07-17
18257200131334Firebird SI FusionOrthofix US LLCFZX2026-07-17
18257200163625PILLAR SA TiOrthofix US LLCFZX2026-07-17