AccuFit RP System RPIF15-CP

GUDID 00840019912396

AccuFit ALIF RP Cover Plate 15mm

PRECISION SPINE, INC.

Spinal fixation plate, non-bioabsorbable
Primary Device ID00840019912396
NIH Device Record Key6cb46556-7a3f-4eb5-a688-b9e0b374b62c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAccuFit RP System
Version Model NumberRPIF15-CP
Catalog NumberRPIF15-CP
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 Usetrue
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
GS100840019912396 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00840019912396]

Moist Heat or Steam Sterilization


[00840019912396]

Moist Heat or Steam Sterilization


[00840019912396]

Moist Heat or Steam Sterilization


[00840019912396]

Moist Heat or Steam Sterilization


[00840019912396]

Moist Heat or Steam Sterilization


[00840019912396]

Moist Heat or Steam Sterilization


[00840019912396]

Moist Heat or Steam Sterilization


[00840019912396]

Moist Heat or Steam Sterilization


[00840019912396]

Moist Heat or Steam Sterilization


[00840019912396]

Moist Heat or Steam Sterilization


[00840019912396]

Moist Heat or Steam Sterilization


[00840019912396]

Moist Heat or Steam Sterilization


[00840019912396]

Moist Heat or Steam Sterilization


[00840019912396]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-05-09
Device Publish Date2019-05-01

On-Brand Devices [AccuFit RP System]

008400199124574.5mm x 35mm SD Screw
008400199124404.5mm x 30mm SD Screw
008400199124334.5mm x 25mm SD Screw
00840019912426AccuFit ALIF RP Set Screw
00840019912419AccuFit ALIF RP Cover Plate 17mm
00840019912402AccuFit ALIF Recessed Plate IF 17mm
00840019912396AccuFit ALIF RP Cover Plate 15mm
00840019912389AccuFit ALIF Recessed Plate IF 15mm
00840019912372AccuFit ALIF RP Cover Plate 13mm
00840019912365AccuFit ALIF Recessed Plate IF 13mm
00840019912358AccuFit ALIF RP Cover Plate 11mm
00840019912341AccuFit ALIF Recessed Plate IF 11mm
00840019912334AccuFit ALIF RP Cover Plate 9mm
00840019912327AccuFit ALIF Recessed Plate IF 9mm

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