PLS

GUDID 00810086190867

DUAL LEAD SCREW DIAMETER 5 MM - LENGTH 35 MM

SINTEA USA, LLC

Bone-screw internal spinal fixation system rod
Primary Device ID00810086190867
NIH Device Record Key46d9bf7f-e589-41e1-9c85-00a80e757efe
Commercial Distribution StatusIn Commercial Distribution
Brand NamePLS
Version Model NumberPLS-535T55
Company DUNS079917057
Company NameSINTEA USA, 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone3054906850
Emailinfo@sinteausa.com
Phone3054906850
Emailinfo@sinteausa.com
Phone3054906850
Emailinfo@sinteausa.com
Phone3054906850
Emailinfo@sinteausa.com
Phone3054906850
Emailinfo@sinteausa.com
Phone3054906850
Emailinfo@sinteausa.com
Phone3054906850
Emailinfo@sinteausa.com
Phone3054906850
Emailinfo@sinteausa.com
Phone3054906850
Emailinfo@sinteausa.com
Phone3054906850
Emailinfo@sinteausa.com
Phone3054906850
Emailinfo@sinteausa.com
Phone3054906850
Emailinfo@sinteausa.com
Phone3054906850
Emailinfo@sinteausa.com
Phone3054906850
Emailinfo@sinteausa.com

Device Dimensions

Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter
Length35 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100810086190867 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MNHOrthosis, Spondylolisthesis Spinal Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00810086190867]

Moist Heat or Steam Sterilization

[00810086190867]

Moist Heat or Steam Sterilization

[00810086190867]

Moist Heat or Steam Sterilization

[00810086190867]

Moist Heat or Steam Sterilization

[00810086190867]

Moist Heat or Steam Sterilization

[00810086190867]

Moist Heat or Steam Sterilization

[00810086190867]

Moist Heat or Steam Sterilization

[00810086190867]

Moist Heat or Steam Sterilization

[00810086190867]

Moist Heat or Steam Sterilization

[00810086190867]

Moist Heat or Steam Sterilization

[00810086190867]

Moist Heat or Steam Sterilization

[00810086190867]

Moist Heat or Steam Sterilization

[00810086190867]

Moist Heat or Steam Sterilization

[00810086190867]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-09-27
Device Publish Date2024-09-19

On-Brand Devices [PLS]

00810086190867DUAL LEAD SCREW DIAMETER 5 MM - LENGTH 35 MM
008100861937143LOCK- Dual-lead multiaxial cannulated fenestrated screw- l.55mm-ø8mm
008100861936913LOCK- Dual-lead multiaxial cannulated fenestrated screw- l.45mm-ø8mm
008100861935543LOCK- Dual-lead multiaxial cannulated fenestrated screw- l.50mm-ø7mm
008100861935473LOCK- Dual-lead multiaxial cannulated fenestrated screw- l.45mm-ø7mm
008100861934003LOCK- Dual-lead multiaxial cannulated fenestrated screw- l.50mm-ø6mm
008100861933943LOCK- Dual-lead multiaxial cannulated fenestrated screw- l.45mm-ø6mm
00810086191161Dual Lead Screw Ø7 L35mm
00810086191154Dual Lead Screw Ø7 L30mm
00810086191055Dual Lead Screw Ø6 L55mm
00810086191000Dual Lead Screw Ø6 L30mm
00810086190898Dual Lead Screw Ø5 L50mm
00810086190881Dual Lead Screw Ø5 L45mm
00810086190874Dual Lead Screw Ø5 L40mm
00810086190737Dual Lead Screw ø4mm L45mm
00810086190713Dual Lead Screw ø4mm L35mm
00810086190706Dual Lead Screw ø4mm L30mm
00810086190720Dual Lead Screw ø4mm L40mm
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