FDA.reportPublic FDA data

Onyx PLIF PEEK

Primary DI
B104P092511000
Brand
Onyx PLIF PEEK
Company
GLASIR MEDICAL LP
Model
P09251100
Catalog number
P09251100
Device description
11mm Onyx Parallel PLIF PEEK
Published
2017-04-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110659000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110659000MEDICAL CONCEPTS INTERBODY FUSION SYSTEMMedical Concepts, Inc.2011-09-13MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B104P092511000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
066151033
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B104CL0300Emerald Cervical PEEKC-L-030C-L-0302017-04-05
B104CL0310Emerald Cervical PEEKC-L-031 C-L-031 2017-03-29
B104CL0320Emerald Cervical PEEKC-L-032 C-L-032 2017-04-05
B104CL0330Emerald Cervical PEEKC-L-033 C-L-033 2017-04-05
B104CL0340Emerald Cervical PEEKC-L-034 C-L-034 2017-04-05
B104CL0350Emerald Cervical PEEKC-L-035 C-L-035 2017-04-05
B104CL0360Emerald Cervical PEEKC-L-036 C-L-036 2017-04-05
B104CL0370Emerald Cervical PEEKC-L-037 C-L-037 2017-04-05
B104CP0300Emerald Cervical PEEKC-P-030 C-P-030 2017-04-05
B104CP0310Emerald Cervical PEEKC-P-031 C-P-031 2017-04-05
B104CP0320Emerald Cervical PEEKC-P-032 C-P-032 2017-04-05
B104CP0330Emerald Cervical PEEKC-P-033 C-P-033 2017-04-05
B104CP0340Emerald Cervical PEEKC-P-034 C-P-034 2017-04-05
B104CP0350Emerald Cervical PEEKC-P-035 C-P-035 2017-04-05
B104CP0360Emerald Cervical PEEKC-P-036 C-P-036 2017-04-05
B104CP0370Emerald Cervical PEEKC-P-037 C-P-037 2017-04-05
B104P092506000Onyx PLIF PEEKP09250600P092506002017-04-05
B104P092507000Onyx PLIF PEEKP09250700P092507002017-04-05
B104P092507100Onyx PLIF PEEKP09250710P092507102017-04-05
B104P092508000Onyx PLIF PEEKP09250800P092508002017-04-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800043912870N/ATDM Co., Ltd.MAX2026-06-02
08800043912887N/ATDM Co., Ltd.MAX2026-06-02
08800043912894N/ATDM Co., Ltd.MAX2026-06-02
08800043912900N/ATDM Co., Ltd.MAX2026-06-02
08800043912917N/ATDM Co., Ltd.MAX2026-06-02
08800043912924N/ATDM Co., Ltd.MAX2026-06-02
08800043912931N/ATDM Co., Ltd.MAX2026-06-02
08800043912948N/ATDM Co., Ltd.MAX2026-06-02
08800043912955N/ATDM Co., Ltd.MAX2026-06-02
08800043912962N/ATDM Co., Ltd.MAX2026-06-02
08800043912979N/ATDM Co., Ltd.MAX2026-06-02
08800043912986N/ATDM Co., Ltd.MAX2026-06-02
08800043912993N/ATDM Co., Ltd.MAX2026-06-02
08800043913006N/ATDM Co., Ltd.MAX2026-06-02
08800043913013N/ATDM Co., Ltd.MAX2026-06-02
08800043913020N/ATDM Co., Ltd.MAX2026-06-02
08800043913037N/ATDM Co., Ltd.MAX2026-06-02
08800043913044N/ATDM Co., Ltd.MAX2026-06-02
08800043913051N/ATDM Co., Ltd.MAX2026-06-02
08800043913068N/ATDM Co., Ltd.MAX2026-06-02
08800043913075N/ATDM Co., Ltd.MAX2026-06-02
08800043964183N/ATDM Co., Ltd.MAX2026-06-02
08800043964190N/ATDM Co., Ltd.MAX2026-06-02
08800043964206N/ATDM Co., Ltd.MAX2026-06-02
08800043964213N/ATDM Co., Ltd.MAX2026-06-02
08800043964220N/ATDM Co., Ltd.MAX2026-06-02
08800043964237N/ATDM Co., Ltd.MAX2026-06-02
08800043964244N/ATDM Co., Ltd.MAX2026-06-02
08800043964251N/ATDM Co., Ltd.MAX2026-06-02
08800043964268N/ATDM Co., Ltd.MAX2026-06-02