ShurFit Interbody Device 68-SC-0200

GUDID 00840019935623

TLIF/PLIF/TPLIF Instrument Case

PRECISION SPINE, INC.

Orthopaedic surgical procedure kit, non-medicated, reusable
Primary Device ID00840019935623
NIH Device Record Key2ece6d33-8ec5-47b4-92a4-e2e3fb062dc5
Commercial Distribution StatusIn Commercial Distribution
Brand NameShurFit Interbody Device
Version Model Number68-SC-0200
Catalog Number68-SC-0200
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
GS100840019935623 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019935623]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-09-11
Device Publish Date2019-09-03

On-Brand Devices [ShurFit Interbody Device]

00840019930819 TLIF Sizer 7mm x 24mm
00840019930864 TLIF Sizer 11mm x 30mm
00840019930833 TLIF Sizer 11mm x 24mm
00840019930826 TLIF Sizer 9mm x 24mm
00840019909969TLIF Cage Peek 16mm x 30mm
00840019909952TLIF Cage Peek 14mm x 30mm
00840019909945TLIF Cage Peek 12mm x 30mm
00840019909938TLIF Cage Peek 11mm x 30mm
00840019909921TLIF Cage Peek 10mm x 30mm
00840019909914TLIF Cage Peek 9mm x 30mm
00840019909907TLIF Cage Peek 8mm x 30mm
00840019909891TLIF Cage Peek 7mm x 30mm
00840019909884TLIF Cage Peek 6mm x 30mm
00840019909877TLIF Cage Peek 16mm x 24mm
00840019909860TLIF Cage Peek 14mm x 24mm
00840019909853TLIF Cage Peek 12mm x 24mm
00840019909846TLIF Cage Peek 11mm x 24mm
00840019909839TLIF Cage Peek 10mm x 24mm
00840019909822TLIF Cage Peek 9mm x 24mm
00840019909815TLIF Cage Peek 8mm x 24mm
00840019909808TLIF Cage Peek 7mm x 24mm
00840019909792TLIF Cage Peek 6mm x 24mm
00840019909785PLIF Cage Peek, 16mm x 25mm
00840019909778PLIF Cage Peek, 15mm x 25mm
00840019909761PLIF Cage Peek, 14mm x 25mm
00840019909754PLIF Cage Peek, 13mm x 25mm
00840019909747PLIF Cage Peek, 12mm x 25mm
00840019909730PLIF Cage Peek, 11mm x 25mm
00840019909723PLIF Cage Peek, 10mm x 25mm
00840019909716PLIF Cage Peek, 9mm x 25mm
00840019909709PLIF Cage Peek, 8mm x 25mm
00840019909693PLIF Cage Peek 16mm x 22mm
00840019909686PLIF Cage Peek 15mm x 22mm
00840019909679PLIF Cage Peek 14mm x 22mm
00840019909662PLIF Cage Peek 13mm x 22mm
00840019909655PLIF Cage Peek 12mm x 22mm
00840019909648PLIF Cage Peek 11mm x 22mm
00840019909631PLIF Cage Peek 10mm x 22mm
00840019909624PLIF Cage Peek 9mm x 22mm
00840019909617PLIF Cage Peek, 8mm x 22mm
00840019930895TPLIF Convex Caddy
00840019930888TLIF Caddy
00840019930871PLIF Caddy
00840019930857TLIF Sizer 9mm x 30mm
00840019930840TLIF Sizer 7mm x 30mm
0084001992364415mm PLIF 15 degree Paddle Shaver
0084001991074330 x 14mm 15 degree O TPLIF
0084001991073630 x 12mm 15 degree O TPLIF
0084001991072930 x 10mm 15 degree O TPLIF
0084001991071230 x 14mm 10 degree O TPLIF

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