FDA.reportPublic FDA data

PLIF - Posterior Lumbar Interbody Fusion Sysytem

Primary DI
00814008020669
Brand
PLIF - Posterior Lumbar Interbody Fusion Sysytem
Company
NVISION BIOMEDICAL TECHNOLOGIES, INC.
Model
PL-009-S
Device description
10x22 9mm 0 Degrees
Published
2015-10-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K142594000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142594000nva, nvp, nvtNvision Biomedical Technologies, LLC2014-11-28MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814008020669PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814008020669008140080206698140080206690814008020669

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
Angle0degree
Device Size Text, specify0
Height9Millimeter
Length10Millimeter
Width22Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
210-545-3713diana@nvisionbiomed.com

Regulatory Flags#

DUNS number
047486041
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810005668088TrigonWD-1001C-7002026-04-24
00810005668095TrigonMTP-22-08-002026-04-24
00810005668101TrigonMTP-22-10-002026-04-24
00810005668118TrigonMTP-22-12-002026-04-24
00810005668125TrigonWD-1000T-MWIS2026-04-24
00810005668187TrigonMTP-18-08-002026-04-24
00810135963565TrigonMTP-18-10-002026-04-24
00810135963572TrigonMTP-18-12-002026-04-24
00810005668132TrigonMTP-22-08T-002026-04-23
00810005668149TrigonMTP-22-10T-002026-04-23
00810005668156TrigonMTP-22-12T-002026-04-23
00810135963589TrigonMTP-18-08T-002026-04-23
00810135963596TrigonMTP-18-10T-002026-04-23
00810135963602TrigonMTP-18-12T-002026-04-23
00810135960502Retropsoas ElectrodeELEC1000-042023-10-25
00810135960519Retropsoas ElectrodeELEC1000-062023-10-25
00810135960526Retropsoas ElectrodeELEC1000-082023-10-25
00810135960533Retropsoas ElectrodeELEC1000-102023-10-25
00810135960540Retropsoas ElectrodeELEC21002023-10-25
00810135960557Retropsoas ElectrodeELEC22402023-10-25

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