Amplitude

FDA Filings

This page includes the latest FDA filings for Amplitude. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3009590742
• FEI Number: 3009590742
• Name: AMPLITUDE
• Owner & Operator: AMPLITUDE
• Contact Address: 11 Cours Jacques Offenbach Zone Mozart 2; Valence FR-26 Drome 26000 FR
• Official Correspondent:
  • Mireille A Lemery
  • 33-04-75813495-x
• US Agent:
  • Carol WEISE
  • 972 3584715
  • Carol.WEISE@amplitude-ortho.com
• Importing Logistics Registration:
  • Importer: Amplitude Orthopaedic Corp
  • Address: 2711 Centerville Road, Suite 400 Wilmington ; Marshallton, DE 19808 UNITED STATES
  • Importer Type: Agent
• Importing Logistics Registration:
  • Importer: Amplitude Orthopedics Corp
  • Address: 2711 Centerville Road, Suite 400 Wilmington ; Marshallton, DE 19808 UNITED STATES
  • Importer Type: Agent
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 11 Cours Jacques Offenbach Zone Mozart 2; Valence Drome, 26000 FR
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

• Registration Number: 3014197657
• FEI Number: 3014197657
• Name: AMPLITUDE
• Owner & Operator: AMPLITUDE
• Contact Address: 11 Cours Jacques Offenbach Zone Mozart 2; Valence FR-26 Drome 26000 FR
• Official Correspondent:
  • Mireille A Lemery
  • 33-04-75813495-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 13 Prestige Circle Suite 100; Allen, TX 75002 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K170613 | JWH AMPLITUDE	Tibial Tray	2018-06-12
PMN K170613 | JWH AMPLITUDE	Tibial Tray	2018-06-12
PMN K170613 | JWH AMPLITUDE	Tibial Tray insert	2018-06-12
PMN K170613 | JWH AMPLITUDE	Tibial Tray insert	2018-06-12
PMN K170613 | JWH AMPLITUDE	Tibial Tray Insert base	2018-06-12
PMN K170613 | JWH AMPLITUDE	Tibial Tray Insert base	2018-06-12
PMN K170613 | JWH AMPLITUDE	Patella Trial	2018-06-12
PMN K170613 | JWH AMPLITUDE	Patella Trial	2018-06-12
PMN K170613 | JWH AMPLITUDE	Monoblock Trial	2018-06-12
PMN K170613 | JWH AMPLITUDE	Monoblock Trial	2018-06-12
PMN K170613 | JWH AMPLITUDE	Femoral Trial	2018-06-12
PMN K170613 | JWH AMPLITUDE	Femoral Trial	2018-06-12
PMN K170613 | JWH AMPLITUDE	Femoarl Trial Insert	2018-06-12
PMN K170613 | JWH AMPLITUDE	Femoarl Trial Insert	2018-06-12
PMN K170613 | JWH AMPLITUDE	Crescendo Tibial Component Cemented	2018-06-12
PMN K170613 | JWH AMPLITUDE	Crescendo Tibial Component Cemented	2018-06-12
PMN K170613 | JWH AMPLITUDE	Crescendo Patella Component	2018-06-12
PMN K170613 | JWH AMPLITUDE	Crescendo Patella Component	2018-06-12
PMN K170613 | JWH AMPLITUDE	Crescendo Meniscal Insert PS	2018-06-12
PMN K170613 | JWH AMPLITUDE	Crescendo Meniscal Insert PS	2018-06-12
PMN K170613 | JWH AMPLITUDE	Crescendo Meniscal Insert CR Ultracongruent	2018-06-12
PMN K170613 | JWH AMPLITUDE	Crescendo Meniscal Insert CR Ultracongruent	2018-06-12
PMN K170613 | JWH AMPLITUDE	Crescendo Meniscal Insert CR Ultracongruent 13mm	2018-06-12
PMN K170613 | JWH AMPLITUDE	Crescendo Meniscal Insert CR Ultracongruent 13mm	2018-06-12
PMN K170613 | JWH AMPLITUDE	Crescendo Meniscal Insert CR Standard	2018-06-12
PMN K170613 | JWH AMPLITUDE	Crescendo Meniscal Insert CR Standard	2018-06-12
PMN K170613 | JWH AMPLITUDE	Crescendo Femoral Component Cemented - PS	2018-06-12
PMN K170613 | JWH AMPLITUDE	Crescendo Femoral Component Cemented - PS	2018-06-12
PMN K170613 | JWH AMPLITUDE	Crescendo Femoral Component Cemented - CR	2018-06-12
PMN K170613 | JWH AMPLITUDE	Crescendo Femoral Component Cemented - CR	2018-06-12
JEB AMPLITUDE	Shoe for E.T.O.I.L.E	2018-03-28
JEB AMPLITUDE	Shoe for E.T.O.I.L.E	2018-03-28
JEB AMPLITUDE	Posterior support block for E.T.O.I.L.E	2018-03-28
JEB AMPLITUDE	Posterior support block for E.T.O.I.L.E	2018-03-28
JEB AMPLITUDE	Orthopedic tray for E.T.O.I.L.E	2018-03-28
JEB AMPLITUDE	Orthopedic tray for E.T.O.I.L.E	2018-03-28
JEB AMPLITUDE	Orthopedic table EXTENSION E.T.O.I.L.E	2018-03-28
JEB AMPLITUDE	Orthopedic table EXTENSION E.T.O.I.L.E	2018-03-28
JEB AMPLITUDE	Connector for E.T.O.I.L.E	2018-03-28
JEB AMPLITUDE	Connector for E.T.O.I.L.E	2018-03-28
KTZ AMPLITUDE	TOWNLEY Caliper 115 mm	2017-12-21
HWT AMPLITUDE	Template for Clinical Use	2017-12-15
PMN K133370 | LZO AMPLITUDE	SKYLON	2017-09-05
PMN K133370 | LZO AMPLITUDE	SKYLON	2017-09-05
PMN K133370 | LPH AMPLITUDE	SKYLON	2017-09-05
PMN K133370 | LPH AMPLITUDE	SKYLON	2017-09-05
PMN K133370 | KWY AMPLITUDE	SKYLON	2017-09-05
PMN K133370 | KWY AMPLITUDE	SKYLON	2017-09-05
PMN K133370 | JDI AMPLITUDE	SKYLON	2017-09-05
PMN K133370 | JDI AMPLITUDE	SKYLON	2017-09-05
PMN K121297 | MEH AMPLITUDE	Vento Cup	2017-09-05
PMN K121297 | MEH AMPLITUDE	Vento Cup	2017-09-05
PMN K121297 | MEH AMPLITUDE	Stratus Stem	2017-09-05
PMN K121297 | MEH AMPLITUDE	Stratus Stem	2017-09-05
PMN K121297 | MEH AMPLITUDE	Sirocco Stem	2017-09-05
PMN K121297 | MEH AMPLITUDE	Sirocco Stem	2017-09-05
PMN K121297 | LPH AMPLITUDE	Vento Cup	2017-09-05
PMN K121297 | LPH AMPLITUDE	Vento Cup	2017-09-05
PMN K121297 | LPH AMPLITUDE	Stratus Stem	2017-09-05
PMN K121297 | LPH AMPLITUDE	Stratus Stem	2017-09-05
PMN K121297 | LPH AMPLITUDE	Sirocco Stem	2017-09-05
PMN K121297 | LPH AMPLITUDE	Sirocco Stem	2017-09-05
PMN K161155 | MEH AMPLITUDE	Stratus Stems lateralized	2017-08-31
PMN K161155 | MEH AMPLITUDE	Stratus Stems lateralized	2017-08-31
PMN K161155 | MEH AMPLITUDE	Status stem Hight Offset Collared	2017-08-31
PMN K161155 | MEH AMPLITUDE	Status stem Hight Offset Collared	2017-08-31
PMN K161155 | KWZ AMPLITUDE	Stratus Stems lateralized	2017-08-31
PMN K161155 | KWZ AMPLITUDE	Stratus Stems lateralized	2017-08-31
PMN K161155 | KWZ AMPLITUDE	Status stem Hight Offset Collared	2017-08-31
PMN K161155 | KWZ AMPLITUDE	Status stem Hight Offset Collared	2017-08-31
PMN K153131 | MEH AMPLITUDE	Vento Cup constrained liners	2017-08-29
PMN K153131 | MEH AMPLITUDE	Vento Cup constrained liners	2017-08-29
PMN K153131 | MEH AMPLITUDE	Vento Cup 20 deg hooded	2017-08-29
PMN K153131 | MEH AMPLITUDE	Vento Cup 20 deg hooded	2017-08-29
PMN K153131 | LPH AMPLITUDE	Vento Cup constrained liners	2017-08-29
PMN K153131 | LPH AMPLITUDE	Vento Cup constrained liners	2017-08-29
PMN K153131 | LPH AMPLITUDE	Vento Cup 20 deg hooded	2017-08-29
PMN K153131 | LPH AMPLITUDE	Vento Cup 20 deg hooded	2017-08-29
PMN K153131 | KWZ AMPLITUDE	Vento Cup constrained liners	2017-08-29
PMN K153131 | KWZ AMPLITUDE	Vento Cup constrained liners	2017-08-29
PMN K153131 | KWZ AMPLITUDE	Vento Cup 20 deg hooded	2017-08-29
PMN K153131 | KWZ AMPLITUDE	Vento Cup 20 deg hooded	2017-08-29
LXH AMPLITUDE	Surgical instruments	2017-03-29
LXH AMPLITUDE	Surgical instruments	2017-03-29
LRY AMPLITUDE	Punch	2017-03-29
LRY AMPLITUDE	Punch	2017-03-29
HXX AMPLITUDE	Screwdriver	2017-03-29
HXX AMPLITUDE	Screwdriver	2017-03-29
HXC AMPLITUDE	Wrench	2017-03-29
HXC AMPLITUDE	Wrench	2017-03-29
HXB AMPLITUDE	Probe	2017-03-29
HXB AMPLITUDE	Probe	2017-03-29
HWR AMPLITUDE	Driver	2017-03-29
HWR AMPLITUDE	Driver	2017-03-29
HWM AMPLITUDE	Osteotome	2017-03-29
HWM AMPLITUDE	Osteotome	2017-03-29
HWE AMPLITUDE	Surgical instrument	2017-03-29
HWE AMPLITUDE	Surgical instrument	2017-03-29
HWA AMPLITUDE	Impactor	2017-03-29
HWA AMPLITUDE	Impactor	2017-03-29
HTZ AMPLITUDE	Cutting instrument	2017-03-29
HTZ AMPLITUDE	Cutting instrument	2017-03-29
HTO AMPLITUDE	Reamer	2017-03-29
HTO AMPLITUDE	Reamer	2017-03-29
HTD AMPLITUDE	Forceps	2017-03-29
HTD AMPLITUDE	Forceps	2017-03-29
GDJ AMPLITUDE	Clamp	2017-03-29
GDJ AMPLITUDE	Clamp	2017-03-29
GAD AMPLITUDE	Retractor	2017-03-29
GAD AMPLITUDE	Retractor	2017-03-29
GAC AMPLITUDE	Rasp	2017-03-29
GAC AMPLITUDE	Rasp	2017-03-29
FZY AMPLITUDE	Hammer	2017-03-29
FZY AMPLITUDE	Hammer	2017-03-29
FZX AMPLITUDE	Guide	2017-03-29
FZX AMPLITUDE	Guide	2017-03-29
FZO AMPLITUDE	Chisel	2017-03-29
FZO AMPLITUDE	Chisel	2017-03-29
PMN K161414 | JWH AMPLITUDE	Anatomic Total Knee System	2017-03-28
PMN K161414 | JWH AMPLITUDE	Anatomic Total Knee System	2017-03-28
HWB AMPLITUDE	Extractor	2017-03-28
HWB AMPLITUDE	Extractor	2017-03-28
HTW AMPLITUDE	Drill bit	2017-03-28
HTW AMPLITUDE	Drill bit	2017-03-28
PMN K161414 AMPLITUDE	Anatomic Total Knee System	2017-01-19

Similar & Related FDA Registered Companies

• AMPLITUDE ORTHOPEDICS CORP.
• Amplitude Orthopaedic Corp
• AMPLITUDE SAS