PEEK RCI Screw

GUDID 09348215059101

SIGNATURE ORTHOPAEDICS PTY LTD

Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable Tendon/ligament bone anchor, non-bioabsorbable
Primary Device ID09348215059101
NIH Device Record Keyba70bff6-4ee4-4e6a-a972-3d1ecd2ea124
Commercial Distribution StatusIn Commercial Distribution
Brand NamePEEK RCI Screw
Version Model Number121-05-6230
Company DUNS751993028
Company NameSIGNATURE ORTHOPAEDICS PTY LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109348215059101 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MBIFastener, Fixation, Nondegradable, Soft Tissue

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-05
Device Publish Date2023-05-26

On-Brand Devices [PEEK RCI Screw]

09348215082109121-05-6271
09348215082093121-05-6231
09348215082086121-05-5231
09348215082079121-05-2370
09348215082062121-05-2320
09348215081881121-05-1370
09348215081874121-05-1320
09348215081867121-05-0370
09348215059200121-05-9370
09348215059194121-05-9320
09348215059187121-05-9270
09348215059170121-05-8320
09348215059163121-05-8270
09348215059156121-05-8230
09348215059149121-05-7320
09348215059132121-05-7270
09348215059125121-05-7230
09348215059118121-05-6270
09348215059101121-05-6230
09348215059095121-05-5230
09348215122041121-05-9271
09348215122034121-05-8271
09348215122027121-05-8231
09348215122010121-05-7271
09348215122003121-05-7231
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