FDA.reportPublic FDA data

AMPLITUDE

Matched from indexed company URL: Amplitude

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30095907423009590742AMPLITUDE1N2026-01-0111 Cours Jacques Offenbach Zone Mozart 2 Valence Drome FR 26000
30141976573014197657AMPLITUDE1N2020-04-2513 Prestige Circle Suite 100 Allen TX US 75002

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
03701089514330VENTO Fixation Screw - 1-01-12-9130+0033475418741regulatoryaffairs@amplitude-ortho.com
03701089514347VENTO Fixation Screw - 1-01-12-9135+0033475418741regulatoryaffairs@amplitude-ortho.com
03701089514354VENTO Fixation Screw - 1-01-12-9140+0033475418741regulatoryaffairs@amplitude-ortho.com
03701089514361VENTO Fixation Screw - 1-01-12-9150+0033475418741regulatoryaffairs@amplitude-ortho.com
03701089514378VENTO Fixation Screw - 1-01-12-9155+0033475418741regulatoryaffairs@amplitude-ortho.com
03701089514385VENTO Fixation Screw - 1-01-12-9160+0033475418741regulatoryaffairs@amplitude-ortho.com
03701089514392VENTO Fixation Screw - 1-01-12-9165+0033475418741regulatoryaffairs@amplitude-ortho.com
03701089514408VENTO Fixation Screw - 1-01-12-9170+0033475418741regulatoryaffairs@amplitude-ortho.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2062681950538238K230078TRAX® CR Total Knee SystemJWH2023-11-03
2141511850634001K170613Genius Total Knee SystemJWH2017-07-17
2062681850634001K170613Genius Total Knee SystemJWH2017-07-17
2062681968135007K161414Anatomic Total Knee SystemJWH2017-01-19
2141511968135007K161414Anatomic Total Knee SystemJWH2017-01-19
2141511032193868K161155Origin Coxa Vara Hip StemMEH2016-07-19
2062681032193868K161155Origin Coxa Vara Hip StemMEH2016-07-19
2141511760248746K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular LinerMEH2016-06-03
2062681760248746K153131Logical C-Series Acetabular Shell, Logical Constrained Liner, Logical Constrained Liner Collar, Logical 20° Hooded Acetabular LinerMEH2016-06-03
2062681326180326K133370REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CELPH2014-07-22
2141511326180326K133370REMEDY HIP STEM, PEGASUS HIP STEM, EVOLVE HELIOS HIP STEM, EVOLVE MASTERS HIP STEM, EVOLVE DISTAL CENTRALIZER, EVOLVE CELPH2014-07-22
2141511205265154K121297ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULARLPH2012-12-28
2062681205265154K121297ORIGIN HIP STEM, FEMORAL HEAD, LOGICAL PX-SERIES ACETABULAR SHELL, LOCIGAL G-SERIES ACETABULAR SHELL, LOGICAL ACETABULARLPH2012-12-28
2062681103700511
2141511103700511
2141511161042534
2062681161042534
2062681178214053
2141511178214053
2141511210280245
2062681236608100
2141511236608100
2141511258861671
2141511283314090
2062681283314090
2062681332557492
2141511332557492
2062681362684578
2141511362684578
2141511391524021
2062681391524021
2141511415017431
2062681415017431
2062681431569301
2141511431569301
2141511482181622
2062681482181622
2141511488169287
2062681488169287
2141511518838403
2062681518838403
2141511530490750
2062681530490750
2062681627865787
2141511627865787
2141511751161153
2062681751161153
2062681810229102
2141511810229102
2062681821302012
2141511821302012
2141511971860156
2062681971860156
2062681995644623
2141511995644623
2062682059182318
2141512059182318
2062681210280245
2062681258861671

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH62023-11-03
MEH42016-07-19
LPH42014-07-22

PMN#

GUDID#

80 records. Showing 1-40. Next