Amplify Surgical, Inc.

Address:9272 Jeronimo Road,Irvine,CA,92618,US

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Intervertebral Fusion Device With Bone Graft, Lumbar (MAX) (10)

Premarket Exempt

Clear

KIT DUALX TLIF 8 DEG x 13-16MM - B707125330060090 Catalog Number :

Device Description : TLIF IMPLANTLordosis & Heights: 8° x 13-16mmCollapsed Width (mm): 12.32Expanded TLIF IMPLANTLordosis & Heights: 8° x 13-16mmCollapsed Width (mm): 12.32Expanded Width (mm): 21.1Collapsed Height (mm): 13.21Expanded Height (mm): 16.5Collapsed Length (mm): 39.47Expanded Length (mm): 33.4TLIF SCREW

Device Class : 2

Duns Number: 081021000

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

KIT DUALX TLIF 8 DEG x 14-17MM - B707125330060100 Catalog Number :

Device Description : TLIF IMPLANTLordosis & Heights: 8° x 14-17mmCollapsed Width (mm): 12.32Expanded TLIF IMPLANTLordosis & Heights: 8° x 14-17mmCollapsed Width (mm): 12.32Expanded Width (mm): 21.1Collapsed Height (mm): 14.21Expanded Height (mm): 17.5Collapsed Length (mm): 39.47Expanded Length (mm): 33.4TLIF SCREW

Device Class : 2

Duns Number: 081021000

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

DualX Implant Retainer Shaft - B707125340640 Catalog Number :

Device Description : DUALX IMPLANT RETAINER SHAFT ASSEMBLY

Device Class : 2

Duns Number: 081021000

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

DualX Implant Retainer Shaft Short - B70712534064S0 Catalog Number :

Device Description : DUALX IMPLANT RETAINER SHAFT SHORT ASSEMBLY

Device Class : 2

Duns Number: 081021000

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

DUALX SCREW DRIVER - B707125340930 Catalog Number :

Device Description : Dual X Screw Driver

Device Class : 2

Duns Number: 081021000

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

DUALX SCREW DRIVER SLEEVE - B707125340940 Catalog Number :

Device Description : Dual X Screw Driver Sleeve

Device Class : 2

Duns Number: 081021000

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

Dual X Torque Limiting Handle - B707125340950 Catalog Number :

Device Description : Dual X Torque Limiting Handle

Device Class : 2

Duns Number: 081021000

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

DUALX GRAFT FUNNEL - B707125340960 Catalog Number :

Device Description : DUALX GRAFT FUNNEL

Device Class : 2

Duns Number: 081021000

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

DUALX COUNTER TORQUE HANDLE - B707125341040 Catalog Number :

Device Description : Dual X Counter Torque Handle

Device Class : 2

Duns Number: 081021000

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

dualX T-HANDLE - B707125341050 Catalog Number :

Device Description : Dual X T-Handle

Device Class : 2

Duns Number: 081021000

Premarket Exempt : No

Product Code : MAX

Prescription Use : Yes

Device Count : 1

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