FDA.reportPublic FDA data

SAHARA™ Stabilization System

Primary DI
10888857462199
Brand
SAHARA™ Stabilization System
Company
VB Spine LLC
Model
7908-2D226012L10-G2
Catalog number
7908-2D226012L10-G2
Device description
Expandable Lateral Interbody, Size 22x60x12 mm 10°
Published
2020-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral fusion device with bone graft, lumbar
OVDIntervertebral fusion device with integrated fixation, lumbar

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190179000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190179000SAHARA Stabilization SystemK2m, Inc.2019-10-03OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857462199PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885746219910888857462199

GMDN Terms#

Term, Definition table
TermDefinition
Vertebral body prosthesisAn implantable device designed to replace one or more vertebral body(s) that has collapsed or been surgically removed due to trauma, tumour or degenerative disease. Also known as a corpectomy or vertebrectomy spacer, it is in the form of a one-piece or modular hollow cylinder made of inorganic materials (e.g., metal, polymer). It is typically used with supplemental spinal fixation and/or bone graft, and some types are adjustable for in situ adjustment of prosthesis height to allow intraoperative distraction of adjacent vertebrae.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle10degree
Height12Millimeter
Length60Millimeter
Width22Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(571)919-2000mark.zellers@stryker.com

Regulatory Flags#

DUNS number
119508156
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10888857596740NAPA Access System8030-100228030-100222026-07-31
10888857596757NAPA Access System8030-100238030-100232026-07-31
10888857596764NAPA Access System8030-100248030-100242026-07-31
10888857596771NAPA Access System8030-100258030-100252026-07-31
10888857596788NAPA Access System8030-100268030-100262026-07-31
10888857596795NAPA Access System8030-100278030-100272026-07-31
10888857596801NAPA Access System8030-100288030-100282026-07-31
10888857596818NAPA Access System8030-100298030-100292026-07-31
10888857596825NAPA Access System8030-100308030-100302026-07-31
10888857596832NAPA Access System8030-100318030-100312026-07-31
10888857596849NAPA Access System8030-100328030-100322026-07-31
10888857596856NAPA Access System8030-100338030-100332026-07-31
10888857596863NAPA Access System8030-100348030-100342026-07-31
10888857596870NAPA Access System8030-100358030-100352026-07-31
10888857596887NAPA Access System8030-100368030-100362026-07-31
10888857000018NILE™ Alternative Fixation System5416-F03730-SG5416-F03730-SG2015-09-24
10888857000025NILE™ Alternative Fixation System5416-F04730-SG5416-F04730-SG2015-09-24
10888857018587CAYMAN® Plate System1201-160221201-160222015-09-24
10888857018594CAYMAN® Plate System1201-160241201-160242015-09-24
10888857018600CAYMAN® Plate System1201-160261201-160262015-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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