FUSION ORTHOPEDICS, LLC

Address:4135 S POWER RD STE 118,Mesa,AZ,85212,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

Screw, Fixation, Bone (HWC) (5) Prosthesis, Subtalar, Plug, Polymer (MJW) (1)

Premarket Exempt

Clear

HammerTech - 00852164007940 Catalog Number : HT-TN-7050

Device Description : HT Ti Sizer Wheel Titanium

Device Class : 2

Duns Number: 080307067

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

HammerTech - 00852164007957 Catalog Number : CD-HT-1000-S

Device Description : Removal Tool PEEK

Device Class : 2

Duns Number: 080307067

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

HammerTech - 00852164007964 Catalog Number : HT-60-0808-S

Device Description : Cup and Cone Reamer Implant System 8mm

Device Class : 2

Duns Number: 080307067

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

HammerTech - 00852164007971 Catalog Number : HT-60-1010-S

Device Description : Cup and Cone Reamer Implant System 10mm

Device Class : 2

Duns Number: 080307067

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

HammerTech - 00852164007988 Catalog Number : HT-60-1212-S

Device Description : Cup and Cone Reamer Implant System 12mm

Device Class : 2

Duns Number: 080307067

Premarket Exempt : No

Product Code : HWC

Prescription Use : Yes

Device Count : 1

LSI Arthroereisis Peg - 00852164007995 Catalog Number : CD-LD-1000

Device Description : Trephine Long

Device Class : 2

Duns Number: 080307067

Premarket Exempt : No

Product Code : MJW

Prescription Use : Yes

Device Count : 1

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