FDA.reportPublic FDA data

AMPLITUDE

Primary DI
03701089527897
Brand
AMPLITUDE
Company
AMPLITUDE SAS
Model
2-0255402
Catalog number
2-0255402
Device description
Threaded Non-Headed Pin Lg 80mm
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
HWEINSTRUMENT, SURGICAL, ORTHOPEDIC, AC-POWERED MOTOR AND ACCESSORY/ATTACHMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWEInstrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/AttachmentGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03701089527897PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03701089527897037010895278973701089527897

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
03701089542326AMPLITUDEAMPLITUDE SASHWE2026-07-29
00841731153135ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153142ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
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00841731153166ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153173ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153180ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153197ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153203ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153210ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153227ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153234ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
00841731153241ARTEMIS TAKEDOWNVILEX LLCHWE2026-07-22
03700879515540airlock®NOVASTEPHWE2026-07-10
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.HWE2026-06-28
04589551366217P300-2A100NAKANISHI INC.HWE2026-06-26
04589551366262P300-2A120NAKANISHI INC.HWE2026-06-26
04589551366316P300-2S100NAKANISHI INC.HWE2026-06-26
04589551366361P300-2S120NAKANISHI INC.HWE2026-06-26
04589551366422PD-IN-2-120NAKANISHI INC.HWE2026-06-26
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00842078130537CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134054CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134061CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09
00842078134078CarilaginatorEXTREMITY MEDICAL, LLCHWE2026-06-09