FDA.reportPublic FDA data

Q Interbody Instruments

Primary DI
10888857579118
Brand
Q Interbody Instruments
Company
VB Spine LLC
Model
8020-90048
Catalog number
8020-90048
Device description
Cascadia AN Q Trial 10x28x9 mm
Published
2026-03-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252873000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252873000Q Interbody InstrumentsK2m, Inc.2026-02-06OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857579118PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885757911810888857579118

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height9Millimeter
Length28Millimeter
Width10Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
119508156
Device count
1
Lot or batch
true
Sterilization required before use
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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00763000989927AXIS HYBRID REF FRAME 9736511MEDTRONIC NAVIGATION, INC.OLO2026-08-07
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