Jones/5th Metatarsal Bone Screw System

GUDID B471102660380

Bone Screw 6.5x38 Headless Short Solid Ti

GRAMERCY EXTREMITY ORTHOPEDICS LLC

Orthopaedic bone screw, non-bioabsorbable, sterile
Primary Device IDB471102660380
NIH Device Record Key46724f4e-50a3-4a6e-a139-fbcc3180285a
Commercial Distribution StatusIn Commercial Distribution
Brand NameJones/5th Metatarsal Bone Screw System
Version Model Number10266038
Company DUNS080068420
Company NameGRAMERCY EXTREMITY 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 Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com
Phone+1(855)436-2278
EmailGEOSupportCenter@gramercyortho.com

Device Dimensions

Outer Diameter6.5 Millimeter
Length38 Millimeter
Outer Diameter6.5 Millimeter
Length38 Millimeter
Outer Diameter6.5 Millimeter
Length38 Millimeter
Outer Diameter6.5 Millimeter
Length38 Millimeter
Outer Diameter6.5 Millimeter
Length38 Millimeter
Outer Diameter6.5 Millimeter
Length38 Millimeter
Outer Diameter6.5 Millimeter
Length38 Millimeter
Outer Diameter6.5 Millimeter
Length38 Millimeter
Outer Diameter6.5 Millimeter
Length38 Millimeter
Outer Diameter6.5 Millimeter
Length38 Millimeter
Outer Diameter6.5 Millimeter
Length38 Millimeter
Outer Diameter6.5 Millimeter
Length38 Millimeter
Outer Diameter6.5 Millimeter
Length38 Millimeter
Outer Diameter6.5 Millimeter
Length38 Millimeter
Outer Diameter6.5 Millimeter
Length38 Millimeter

Operating and Storage Conditions

Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius
Storage Environment TemperatureBetween -10 Degrees Celsius and 55 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB471102660380 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-02-03
Device Publish Date2021-01-26

On-Brand Devices [Jones/5th Metatarsal Bone Screw System]

B4717010001705th Metatarsal Common Kit
B4717010001605th Metatarsal 6.5mm Kit
B4717010001505th Metatarsal 5.5mm Kit
B4717010001405th Metatarsal 4.5mm Kit
B471262000650Tapered Tap, 6.5mm, Cannulated AO
B471262000550Tapered Tap, 5.5mm, Cannulated AO
B471262000450Tapered Tap, 4.5mm, Cannulated AO
B471262000350Cannulated Tap, AO, 3.5mm
B471102661100Bone Screw 6.5x110 Headless Short Solid Ti
B471102661050Bone Screw 6.5x105 Headless Short Solid Ti
B471102661000Bone Screw 6.5x100 Headless Short Solid Ti
B471102660950Bone Screw 6.5x95 Headless Short Solid Ti
B471102660900Bone Screw 6.5x90 Headless Short Solid Ti
B471102660850Bone Screw 6.5x85 Headless Short Solid Ti
B471102660800Bone Screw 6.5x80 Headless Short Solid Ti
B471102660750Bone Screw 6.5x75 Headless Short Solid Ti
B471102660700Bone Screw 6.5x70 Headless Short Solid Ti
B471102660650Bone Screw 6.5x65 Headless Short Solid Ti
B471102660600Bone Screw 6.5x60 Headless Short Solid Ti
B471102660550Bone Screw 6.5x55 Headless Short Solid Ti
B471102660500Bone Screw 6.5x50 Headless Short Solid Ti
B471102660480Bone Screw 6.5x48 Headless Short Solid Ti
B471102660460Bone Screw 6.5x46 Headless Short Solid Ti
B471102660440Bone Screw 6.5x44 Headless Short Solid Ti
B471102660420Bone Screw 6.5x42 Headless Short Solid Ti
B471102660400Bone Screw 6.5x40 Headless Short Solid Ti
B471102660380Bone Screw 6.5x38 Headless Short Solid Ti
B471102660360Bone Screw 6.5x36 Headless Short Solid Ti
B471102660340Bone Screw 6.5x34 Headless Short Solid Ti
B471102660320Bone Screw 6.5x32 Headless Short Solid Ti
B471102660300Bone Screw 6.5x30 Headless Short Solid Ti
B471102650650Bone Screw 5.5x65 Headless Short Solid Ti
B471102650600Bone Screw 5.5x60 Headless Short Solid Ti
B471102650550Bone Screw 5.5x55 Headless Short Solid Ti
B471102650500Bone Screw 5.5x50 Headless Short Solid Ti
B471102650480Bone Screw 5.5x48 Headless Short Solid Ti
B471102650460Bone Screw 5.5x46 Headless Short Solid Ti
B471102650440Bone Screw 5.5x44 Headless Short Solid Ti
B471102650420Bone Screw 5.5x42 Headless Short Solid Ti
B471102650400Bone Screw 5.5x40 Headless Short Solid Ti
B471102650380Bone Screw 5.5x38 Headless Short Solid Ti
B471102650360Bone Screw 5.5x36 Headless Short Solid Ti
B471102650340Bone Screw 5.5x34 Headless Short Solid Ti
B471102650320Bone Screw 5.5x32 Headless Short Solid Ti
B471102650300Bone Screw 5.5x30 Headless Short Solid Ti
B471102640650Bone Screw 4.5x65 Headless Short Solid Ti
B471102640600Bone Screw 4.5x60 Headless Short Solid Ti
B471102640550Bone Screw 4.5x55 Headless Short Solid Ti
B471102640500Bone Screw 4.5x50 Headless Short Solid Ti
B471102640480Bone Screw 4.5x48 Headless Short Solid Ti
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.