FDA.report

Spine Innovation Interbody System

Primary DI
00817722020984
Brand
Spine Innovation Interbody System
Company
SPINE INNOVATION, LLC
Model
90-SDA-412726
Device description
Expansion Wedge, 12mm W x 7mm H x 26mm L
Published
2017-02-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications

CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions

SubmissionSupplement
K153356000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K153356000Spine Innovation Interbody SystemSpine Innovation, LLC2016-01-14MAX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00817722020984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00817722020984008177220209848177220209840817722020984

GMDN Terms

TermDefinition
Polymeric spinal fusion cage, sterileA sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
080376573
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00817722020007Spine Innovation Interbody System90-SDA-0826082017-02-15
00817722020014Spine Innovation Interbody System90-SDA-0830082017-02-15
00817722020021Spine Innovation Interbody System90-SDA-0826092017-02-15
00817722020038Spine Innovation Interbody System90-SDA-0830092017-02-15
00817722020045Spine Innovation Interbody System90-SDA-0826102017-02-15
00817722020052Spine Innovation Interbody System90-SDA-0830102017-02-15
00817722020069Spine Innovation Interbody System90-SDA-0826162017-02-15
00817722020076Spine Innovation Interbody System90-SDA-0926102017-02-15
00817722020083Spine Innovation Interbody System90-SDA-0930102017-02-15
00817722020090Spine Innovation Interbody System90-SDA-0926112017-02-15
00817722020106Spine Innovation Interbody System90-SDA-0930112017-02-15
00817722020113Spine Innovation Interbody System90-SDA-0026112017-02-15
00817722020120Spine Innovation Interbody System90-SDA-0030112017-02-15
00817722020137Spine Innovation Interbody System90-SDA-0026122017-02-15
00817722020144Spine Innovation Interbody System90-SDA-0030122017-02-15
00817722020151Spine Innovation Interbody System90-SDA-0126122017-02-15
00817722020168Spine Innovation Interbody System90-SDA-0130122017-02-15
00817722020175Spine Innovation Interbody System90-SDA-0126132017-02-15
00817722020182Spine Innovation Interbody System90-SDA-0130132017-02-15
00817722020199Spine Innovation Interbody System90-SDA-0226132017-02-15

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