The Bigger Bunion

GUDID G2710121280240

Dorsal Lapidus Guide, Left, 28mm x 24mm

Mios Marketing, LLC

Orthopaedic implant aiming/guiding block, single-use Orthopaedic implant aiming/guiding block, single-use Orthopaedic implant aiming/guiding block, single-use Orthopaedic implant aiming/guiding block, single-use Orthopaedic implant aiming/guiding block, single-use Orthopaedic implant aiming/guiding block, single-use Orthopaedic implant aiming/guiding block, single-use Orthopaedic implant aiming/guiding block, single-use Orthopaedic implant aiming/guiding block, single-use Orthopaedic implant aiming/guiding block, single-use Orthopaedic implant aiming/guiding block, single-use Orthopaedic implant aiming/guiding block, single-use Orthopaedic implant aiming/guiding block, single-use
Primary Device IDG2710121280240
NIH Device Record Keyf4e110ad-8590-4a22-8351-eba0f4cd24af
Commercial Distribution Discontinuation2099-12-31
Commercial Distribution StatusIn Commercial Distribution
Brand NameThe Bigger Bunion
Version Model NumberLapidus
Company DUNS118723037
Company NameMios Marketing, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Unsafe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone877-334-3668
Emailcustomerservice@redpointmedical3d.com
Phone877-334-3668
Emailcustomerservice@redpointmedical3d.com
Phone877-334-3668
Emailcustomerservice@redpointmedical3d.com
Phone877-334-3668
Emailcustomerservice@redpointmedical3d.com
Phone877-334-3668
Emailcustomerservice@redpointmedical3d.com
Phone877-334-3668
Emailcustomerservice@redpointmedical3d.com
Phone877-334-3668
Emailcustomerservice@redpointmedical3d.com
Phone877-334-3668
Emailcustomerservice@redpointmedical3d.com
Phone877-334-3668
Emailcustomerservice@redpointmedical3d.com
Phone877-334-3668
Emailcustomerservice@redpointmedical3d.com
Phone877-334-3668
Emailcustomerservice@redpointmedical3d.com
Phone877-334-3668
Emailcustomerservice@redpointmedical3d.com
Phone877-334-3668
Emailcustomerservice@redpointmedical3d.com

Device Dimensions

Length28 Millimeter
Depth24 Millimeter
Length28 Millimeter
Depth24 Millimeter
Length28 Millimeter
Depth24 Millimeter
Length28 Millimeter
Depth24 Millimeter
Length28 Millimeter
Depth24 Millimeter
Length28 Millimeter
Depth24 Millimeter
Length28 Millimeter
Depth24 Millimeter
Length28 Millimeter
Depth24 Millimeter
Length28 Millimeter
Depth24 Millimeter
Length28 Millimeter
Depth24 Millimeter
Length28 Millimeter
Depth24 Millimeter
Length28 Millimeter
Depth24 Millimeter
Length28 Millimeter
Depth24 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCG2710121280240 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PBFOrthopaedic Surgical Planning And Instrument Guides

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[G2710121280240]

Moist Heat or Steam Sterilization


[G2710121280240]

Moist Heat or Steam Sterilization


[G2710121280240]

Moist Heat or Steam Sterilization


[G2710121280240]

Moist Heat or Steam Sterilization


[G2710121280240]

Moist Heat or Steam Sterilization


[G2710121280240]

Moist Heat or Steam Sterilization


[G2710121280240]

Moist Heat or Steam Sterilization


[G2710121280240]

Moist Heat or Steam Sterilization


[G2710121280240]

Moist Heat or Steam Sterilization


[G2710121280240]

Moist Heat or Steam Sterilization


[G2710121280240]

Moist Heat or Steam Sterilization


[G2710121280240]

Moist Heat or Steam Sterilization


[G2710121280240]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-29
Device Publish Date2022-08-19

Devices Manufactured by Mios Marketing, LLC

G2711020310100 - Intelliguides2023-07-10 Lateral Midfoot Charcot Guide, 31mm x 10mm
G2711020310110 - Intelliguides2023-07-10 Lateral Midfoot Charcot Guide, 30mm x 11mm
G2711020310120 - Intelliguides2023-07-10 Lateral Midfoot Charcot Guide, 31mm x 12mm
G2711020310130 - Intelliguides2023-07-10 Lateral Midfoot Charcot Guide, 31mm x 13mm
G2710820300150 - Intelliguides2023-06-09 Zadik Calcaneal Guide, 30mm x 15°
G2710820300160 - Intelliguides2023-06-09 Zadik Calcaneal Guide, 30mm x 16°
G2710820300170 - Intelliguides2023-06-09 Zadik Calcaneal Guide, 30mm x 17°
G2710820300180 - Intelliguides2023-06-09 Zadik Calcaneal Guide, 30mm x 18°

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