FDA.reportPublic FDA data

AMPLITUDE

Matched from indexed company URL: Amplitude

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
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
03701089509695AMPLITUDE - Extension stem for Total Knee Prosthesis - Cemented - Ø10 Lg 75 mm+0033475418741regulatoryaffairs@amplitude-ortho.com
03701089545358AMPLITUDE - AO Pin driver+0033475418741regulatoryaffairs@amplitude-ortho.com
03701089545365AMPLITUDE - HALL Pin driver+0033475418741regulatoryaffairs@amplitude-ortho.com
03701089546775AMPLITUDE - NM Trial Resurfacing Patella Ø30 - Metal+0033475418741regulatoryaffairs@amplitude-ortho.com
03701089546782AMPLITUDE - NM Trial Resurfacing Patella Ø33 - Metal+0033475418741regulatoryaffairs@amplitude-ortho.com
03701089546799AMPLITUDE - NM Trial Resurfacing Patella Ø36 - Metal+0033475418741regulatoryaffairs@amplitude-ortho.com
03701089546805AMPLITUDE - NM Trial Resurfacing Patella Ø39 - Metal+0033475418741regulatoryaffairs@amplitude-ortho.com
03701089547512AMPLITUDE - Femoral Impactor / Extractor+0033475418741regulatoryaffairs@amplitude-ortho.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2141511850634001K170613Genius Total Knee SystemJWH2017-07-17
2141511968135007K161414Anatomic Total Knee SystemJWH2017-01-19
2141511032193868K161155Origin 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
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
2141511103700511
2141511161042534
2141511178214053
2141511210280245
2141511236608100
2141511258861671
2141511283314090
2141511332557492
2141511362684578
2141511391524021
2141511415017431
2141511431569301
2141511482181622
2141511488169287
2141511518838403
2141511530490750
2141511627865787
2141511751161153
2141511810229102
2141511821302012
2141511971860156
2141511995644623
2141512059182318

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
JWH22017-07-17
MEH22016-07-19
LPH22014-07-22

PMN#

GUDID#

80 records. Showing 1-40. Next