Sochi

GUDID 00843210174105

Polyaxial Screw, 5.0mm x 12mm

Altus Spine, LLC

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID00843210174105
NIH Device Record Key279441fa-5bf1-488a-88fc-f6ba4d056661
Commercial Distribution StatusIn Commercial Distribution
Brand NameSochi
Version Model NumberA16-12-5012
Company DUNS078331322
Company NameAltus Spine, 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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com
Phone610-355-4156
EmailQARA@Altus-Spine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100843210174105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00843210174105]

Moist Heat or Steam Sterilization

[00843210174105]

Moist Heat or Steam Sterilization

[00843210174105]

Moist Heat or Steam Sterilization

[00843210174105]

Moist Heat or Steam Sterilization

[00843210174105]

Moist Heat or Steam Sterilization

[00843210174105]

Moist Heat or Steam Sterilization

[00843210174105]

Moist Heat or Steam Sterilization

[00843210174105]

Moist Heat or Steam Sterilization

[00843210174105]

Moist Heat or Steam Sterilization

[00843210174105]

Moist Heat or Steam Sterilization

[00843210174105]

Moist Heat or Steam Sterilization

[00843210174105]

Moist Heat or Steam Sterilization

[00843210174105]

Moist Heat or Steam Sterilization

[00843210174105]

Moist Heat or Steam Sterilization

[00843210174105]

Moist Heat or Steam Sterilization

[00843210174105]

Moist Heat or Steam Sterilization

[00843210174105]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-08
Device Publish Date2023-12-31

On-Brand Devices [Sochi]

00843210168555Screw Offset, Open, 25mm
00843210168548Screw Offset, Closed, 35mm
00843210168531Screw Offset, Closed, 25mm
00843210168166Clamshell Connector, 5.5mm to 5.5mm
00843210168159Wedding Band 5.5mm to 5.5mm Connector
00843210168142Inline Connector, 5.5mm to 5.5mm
00843210168135Screw Offset, Open, 40mm
00843210168128Screw Offset, Open, 30mm
00843210168111Screw Offset, Open, 20mm
00843210168104Screw Offset, Closed, 40mm
00843210168098Screw Offset, Closed, 30mm
00843210168081Screw Offset, Closed, 20mm
00843210167862Self Tapping Occipital Screw, 4.5mm x 12mm
00843210167855Self Tapping Occipital Screw, 4.5mm x 11mm
00843210166582Polyaxial Screw, 4.0mm x 8mm
00843210166575Polyaxial Screw, 3.5mm x 50mm
00843210166568Polyaxial Screw, 3.5mm x 45mm
00843210166551Polyaxial Screw, 3.5mm x 40mm
00843210166544Polyaxial Screw, 3.5mm x 35mm
00843210166537Polyaxial Screw, 3.5mm x 30mm
00843210166520Polyaxial Screw, 3.5mm x 28mm
00843210166513Polyaxial Screw, 3.5mm x 26mm
00843210166506Polyaxial Screw, 3.5mm x 24mm
00843210166490Polyaxial Screw, 3.5mm x 22mm
00843210166476Polyaxial Screw,3.5mm x 18mm
00843210166469Polyaxial Screw, 3.5mm x 16mm
00843210166452Polyaxial Screw, 3.5mm x 14mm
00843210166445Polyaxial Screw, 3.5mm x 12mm
00843210166346Standard Screw, 4.0mm x 14mm
00843210166339Standard Screw, 4.0mm x 12mm
00843210166322Standard Screw, 4.0mm x 10mm
00843210166315Standard Screw, 4.0mm x 8mm
00843210166308Standard Screw, 3.5mm x 28mm
00843210166292Standard Screw, 3.5mm x 26mm
00843210166285Standard Screw,3.5mm x 24mm
00843210166278Standard Screw, 3.5mm x 22mm
00843210166261Standard Screw, 3.5mm x 20mm
00843210166254Standard Screw, 3.5mm x 18mm
00843210166247Standard Screw, 3.5mm x 16mm
00843210166230Standard Screw, 3.5mm x 14mm
00843210166223Standard Screw, 3.5mm x 12mm
00843210166216Standard Screw, 3.5mm x 10mm
00843210166209Standard Screw, 3.5mm x 8mm
00843210174280Polyaxial Screw, 5.0mm x 15mm
00843210174273Polyaxial Screw, 4.5mm x 25mm
00843210174266Polyaxial Screw, 4.5mm x 15mm
00843210174242Polyaxial Screw, 5.0mm x 50mm
00843210174235Polyaxial Screw, 5.0mm x 45mm
00843210174228Polyaxial Screw, 5.0mm x 40mm
00843210174211Polyaxial Screw, 5.0mm x 35mm

Trademark Results [Sochi]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOCHI
SOCHI
90648497 not registered Live/Pending
SoChi Clothing Company LLC
2021-04-15
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