HammerTech™ Fixation System HT-10-1130-S1

GUDID 00852164007155

Small PIP Implant Single

FUSION ORTHOPEDICS, LLC

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device ID00852164007155
NIH Device Record Key722a0e1a-f5a1-4ca7-b1e0-91f88a263073
Commercial Distribution StatusIn Commercial Distribution
Brand NameHammerTech™ Fixation System
Version Model NumberHT-10-1130-S1
Catalog NumberHT-10-1130-S1
Company DUNS080307067
Company NameFUSION ORTHOPEDICS, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100852164007155 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, Fixation, Bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-11-15

On-Brand Devices [HammerTech™ Fixation System]

00852164007209Reaming Implant Kit 12mm
00852164007193Reaming Implant Kit 10mm
00852164007186Reaming Implant Kit 8mm
00852164007179Large PIP Implant Single
00852164007162Medium PIP Implant Single
00852164007155Small PIP Implant Single
00852164007148Extra Small PIP Implant Single

Trademark Results [HammerTech]

Mark Image

Registration | Serial
Company
Trademark
Application Date
HAMMERTECH
HAMMERTECH
90715358 not registered Live/Pending
Hammer Technologies Pty Ltd
2021-05-17

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.