SIFix 03.700.002

GUDID B946037000020

SIFix Slap Hammer

Nutech Spine, Inc.

Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device IDB946037000020
NIH Device Record Keya2f051ba-fff5-46ee-a1cf-c2beafc5b5d6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIFix
Version Model Number01
Catalog Number03.700.002
Company DUNS080867996
Company NameNutech Spine, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB946037000020 [Primary]

FDA Product Code

LXHOrthopedic Manual Surgical Instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B946037000020]

Moist Heat or Steam Sterilization


[B946037000020]

Moist Heat or Steam Sterilization


[B946037000020]

Moist Heat or Steam Sterilization


[B946037000020]

Moist Heat or Steam Sterilization


[B946037000020]

Moist Heat or Steam Sterilization


[B946037000020]

Moist Heat or Steam Sterilization


[B946037000020]

Moist Heat or Steam Sterilization


[B946037000020]

Moist Heat or Steam Sterilization


[B946037000020]

Moist Heat or Steam Sterilization


[B946037000020]

Moist Heat or Steam Sterilization


[B946037000020]

Moist Heat or Steam Sterilization


[B946037000020]

Moist Heat or Steam Sterilization


[B946037000020]

Moist Heat or Steam Sterilization


[B946037000020]

Moist Heat or Steam Sterilization


[B946037000020]

Moist Heat or Steam Sterilization


[B946037000020]

Moist Heat or Steam Sterilization


[B946037000020]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-24
Device Publish Date2023-11-16

On-Brand Devices [SIFix]

B946037000010Dilator Grabber Assy
B946036000010SIFix Bone Tamp
B946035040010Inserter Knob
B946035030010SIFix Inserter Inner Shaft
B946035000010SIFix Inserter Assy
B946034000030SIFix Iliac Wing Reamer
B946034000020SIFix Drill Bit 42mm Cannulated
B946034000010SIFix Drill Bit 42mm
B9460330000110SIFix Drill Guide Assy
B946033000010SIFix Drill Guide Assy
B946032000050Dilator 5 Assy
B946032000040Dilator 4
B946032000030Dilator 3
B946032000020Dilator 2
B946032000010Dilator 1
B946031100010SIFix Depth Gauge
B9460310026002.6mm Kwire 317mm-Round Tip
B9460310000202.6mm Kwire 410mm-Round Tip
B946037000020SIFix Slap Hammer
B946007020010Pin Puller

Trademark Results [SIFix]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SIFIX
SIFIX
85531371 4426123 Live/Registered
NuTech Spine, Inc.
2012-02-01

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