FDA.reportPublic FDA data

OZARK Cervical Plate System

Primary DI
10888857417656
Brand
OZARK Cervical Plate System
Company
VB Spine LLC
Model
AA01-45F98V-G1
Catalog number
AA01-45F98V-G1
Device description
Plate, 5 Level Size 98 mm
Published
2018-12-12
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
KWQAppliance, fixation, spinal intervertebral body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172104000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172104000Ozark(tm) Cervical Plate SystemK2m, Inc.2017-08-23KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857417656PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885741765610888857417656

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, sterileAn assembly of sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length98Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(703)777-3155mzellers@k2m.com
+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
10888857596894OZARK Cervical Plate SystemPRO-1427-01PRO-1427-012026-05-28
10888857596719Xia® 3PRO-1432-01PRO-1432-012026-05-12
10888857596726Xia® 3PRO-1432-02PRO-1432-022026-05-12
10888857596733Xia® 3PRO-1432-03PRO-1432-032026-05-12
10888857219656CASCADIA™ Interbody System6101-2224012LL8-G26101-2224012LL8-G22016-12-30
10888857219793CASCADIA™ Interbody System6101-2226014LL8-G26101-2226014LL8-G22015-12-16
10888857220966CASCADIA™ Interbody System6101-2224510LL12-G26101-2224510LL12-G22016-12-30
10888857221093CASCADIA™ Interbody System6101-2226012LL12-G26101-2226012LL12-G22016-12-30
10888857221871CASCADIA™ Interbody System6101-2225014LL15-G26101-2225014LL15-G22016-12-30
10888857221895CASCADIA™ Interbody System6101-2226014LL15-G26101-2226014LL15-G22016-12-30
10888857346420CANYON™ Retractor Systems6401-901076401-901072020-06-18
10888857035553RAVINE® Lateral Access System2701-900722701-900722022-02-14
10888857596900OZARK Cervical Plate SystemPRO-1427-10PRO-1427-102026-05-01
10888857596917OZARK Cervical Plate SystemPRO-1427-12PRO-1427-122026-05-01
10888857596924OZARK Cervical Plate SystemPRO-1427-14PRO-1427-142026-05-01
10888857596931OZARK Cervical Plate SystemPRO-1427-16PRO-1427-162026-05-01
10888857596948OZARK Cervical Plate SystemPRO-1427-18PRO-1427-182026-05-01
10888857218765CASCADIA™ Interbody System6101-2224508LP-G26101-2224508LP-G22015-12-16
10888857218888CASCADIA™ Interbody System6101-2225510LP-G26101-2225510LP-G22015-12-16
10888857218895CASCADIA™ Interbody System6101-2226010LP-G26101-2226010LP-G22015-12-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311248360Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248421Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248438Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248445Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248452Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840311248513Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-03
00840493422398RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422404RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422411RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422428RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422435RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422442RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422459RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422466RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422473RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422480RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422497RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422503RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422510RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422527RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422534RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422541RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422558RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422565RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422572RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840493422589RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-06-03
00840311263042Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263059Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263066Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263073Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02