Plateau A 116-966

GUDID 00190837094621

Life Spine, Inc.

Polymeric spinal interbody fusion cage
Primary Device ID00190837094621
NIH Device Record Key8172a486-d16c-4b16-9efe-096c1e905e14
Commercial Distribution StatusIn Commercial Distribution
Brand NamePlateau A
Version Model Number116-966
Catalog Number116-966
Company DUNS183641617
Company NameLife Spine, Inc.
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 Usefalse
Lot Batchtrue
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
GS100190837094621 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ODPIntervertebral fusion device with bone graft, cervical

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00190837094621]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-02-24
Device Publish Date2019-11-07

On-Brand Devices [Plateau A]

00190837095352117-082
00190837095345117-081
00190837095338117-080
00190837095321117-079
00190837095314117-078
00190837095307117-077
00190837095291117-076
00190837095284117-063
00190837095277117-062
00190837095260117-061
00190837095253117-060
00190837095246117-059
00190837095239117-058
00190837095222117-057
00190837095215117-056
00190837095208117-055
00190837095192117-054
00190837095185117-045
00190837095178117-044
00190837095161117-043
00190837095154117-042
00190837095147117-041
00190837095130117-040
00190837095123117-039
00190837095116117-038
00190837095109117-037
00190837095093117-036
00190837095086117-035
00190837095079117-034
00190837095062117-033
00190837095055117-032
00190837095048117-031
00190837095031117-030
00190837095024117-029
00190837095017117-028
00190837095000117-027
00190837094997117-026
00190837094980117-025
00190837094973117-024
00190837094966117-023
00190837094959117-022
00190837094942117-021
00190837094935117-020
00190837094928117-019
00190837094911117-006
00190837094904117-005
00190837094898117-004
00190837094881117-003
00190837094874117-002
00190837094867117-001

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