PSS System 21-1011-CA

GUDID 00840019925884

SureLOK PSS System Implant Tray

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00840019925884
NIH Device Record Key4ae3050e-0cf8-46c3-9dc2-b739657ffed8
Commercial Distribution StatusIn Commercial Distribution
Brand NamePSS System
Version Model Number21-1011-CA
Catalog Number21-1011-CA
Company DUNS079398589
Company NamePRECISION SPINE, INC.
Device Count1
DM Exempttrue
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100840019925884 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWPAppliance, Fixation, Spinal Interlaminal

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019925884]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-04-04
Device Publish Date2019-03-27

On-Brand Devices [PSS System]

00840019931779Ø8.5 x 100mm Cannulated Reduction Pedicle Screw
00840019931762Ø8.5 x 90mm Cannulated Reduction Pedicle Screw
00840019931755Ø8.5 x 80mm Cannulated Reduction Pedicle Screw
00840019931748Ø8.5 x 70mm Cannulated Reduction Pedicle Screw
00840019931731Ø8.5 x 60mm Cannulated Reduction Pedicle Screw
00840019931724Ø8.5 x 55mm Cannulated Reduction Pedicle Screw
00840019931700Ø8.5 x 45mm Cannulated Reduction Pedicle Screw
00840019931694Ø8.5 x 40mm Cannulated Reduction Pedicle Screw
00840019931687Ø8.5 x 35mm Cannulated Reduction Pedicle Screw
00840019931670Ø8.5 x 30mm Cannulated Reduction Pedicle Screw
00840019931663Ø8.5 x 25mm Cannulated Reduction Pedicle Screw
00840019931656Ø7.5 x 60mm Cannulated Reduction Pedicle Screw
00840019931649Ø7.5 x 55mm Cannulated Reduction Pedicle Screw
00840019931632Ø7.5 x 50mm Cannulated Reduction Pedicle Screw
00840019931625Ø7.5 x 45mm Cannulated Reduction Pedicle Screw
00840019931618Ø7.5 x 40mm Cannulated Reduction Pedicle Screw
00840019931595Ø7.5 x 30mm Cannulated Reduction Pedicle Screw
00840019931571Ø6.5 x 60mm Cannulated Reduction Pedicle Screw
00840019931564Ø6.5 x 55mm Cannulated Reduction Pedicle Screw
00840019931557Ø6.5 x 50mm Cannulated Reduction Pedicle Screw
00840019931533Ø6.5 x 40mm Cannulated Reduction Pedicle Screw
00840019931519Ø6.5 x 30mm Cannulated Reduction Pedicle Screw
00840019931502Ø6.5 x 25mm Cannulated Reduction Pedicle Screw
00840019931496Ø5.5 x 60mm Cannulated Reduction Pedicle Screw
00840019931489Ø5.5 x 55mm Cannulated Reduction Pedicle Screw
00840019931472Ø5.5 x 50mm Cannulated Reduction Pedicle Screw
00840019931465Ø5.5 x 45mm Cannulated Reduction Pedicle Screw
00840019931458Ø5.5 x 40mm Cannulated Reduction Pedicle Screw
00840019931434Ø5.5 x 30mm Cannulated Reduction Pedicle Screw
00840019931410Ø8.5 x 100mm Cannulated Pedicle Screw
00840019931403Ø8.5 x 90mm Cannulated Pedicle Screw
00840019931397Ø8.5 x 80mm Cannulated Pedicle Screw
00840019931380Ø8.5 x 70mm Cannulated Pedicle Screw
00840019931366Ø8.5 x 55mm Cannulated Pedicle Screw
00840019931359Ø8.5 x 50mm Cannulated Pedicle Screw
00840019931342Ø8.5 x 45mm Cannulated Pedicle Screw
00840019931335Ø8.5 x 40mm Cannulated Pedicle Screw
00840019931328Ø8.5 x 35mm Cannulated Pedicle Screw
00840019931311Ø8.5 x 30mm Cannulated Pedicle Screw
00840019931304Ø8.5 x 25mm Cannulated Pedicle Screw
00840019931298Ø7.5 x 60mm Cannulated Pedicle Screw
00840019931243Ø7.5 x 35mm Cannulated Pedicle Screw
00840019931236Ø7.5 x 30mm Cannulated Pedicle Screw
00840019931229Ø7.5 x 25mm Cannulated Pedicle Screw
00840019931212Ø6.5 x 60mm Cannulated Pedicle Screw
00840019931199Ø6.5 x 50mm Cannulated Pedicle Screw
00840019931168Ø6.5 x 35mm Cannulated Pedicle Screw
00840019931151Ø6.5 x 30mm Cannulated Pedicle Screw
00840019931144Ø6.5 x 25mm Cannulated Pedicle Screw
00840019931113Ø5.5 x 50mm Cannulated Pedicle Screw

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