Onyx PLIF PEEK P09251310

GUDID B104P092513100

13mm Onyx Lordotic PLIF PEEK

GLASIR MEDICAL LP

Polymeric spinal interbody fusion cage Polymeric spinal interbody fusion cage
Primary Device IDB104P092513100
NIH Device Record Keyed1840c2-fdc1-4354-a3a4-238e38572036
Commercial Distribution StatusIn Commercial Distribution
Brand NameOnyx PLIF PEEK
Version Model NumberP09251310
Catalog NumberP09251310
Company DUNS066151033
Company NameGLASIR MEDICAL LP
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 Usetrue
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 Dimensions

Device Size Text, specify0
Device Size Text, specify0

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB104P092513100 [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

[B104P092513100]

Moist Heat or Steam Sterilization


[B104P092513100]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2017-04-05

On-Brand Devices [Onyx PLIF PEEK]

B104P09251510015mm Onyx Lordotic PLIF PEEK
B104P09251500015mm Onyx Parallel PLIF PEEK
B104P09251400014mm Onyx Parallel PLIF PEEK
B104P09251310013mm Onyx Lordotic PLIF PEEK
B104P09251300013mm Onyx Parallel PLIF PEEK
B104P09251200012mm Onyx Parallel PLIF PEEK
B104P09251110011mm Onyx Lordotic PLIF PEEK
B104P09251100011mm Onyx Parallel PLIF PEEK
B104P09251000010mm Onyx Parallel PLIF PEEK
B104P0925091009mm Onyx Lordotic PLIF PEEK
B104P0925090009mm Onyx Parallel PLIF PEEK
B104P0925080008mm Onyx Parallel PLIF PEEK
B104P0925071007mm Onyx Lordotic PLIF PEEK
B104P0925070007mm Onyx Parallel PLIF PEEK
B104P0925060006mm Onyx Parallel PLIF PEEK

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