FDA.reportPublic FDA data

KASILOF Cervical Plate System

Primary DI
B644KCP14780
Brand
KASILOF Cervical Plate System
Company
KAHTNU SURGICAL
Model
KCP1-478
Device description
KASILOF CERVICAL PLATE, 4 LEVEL, 78mm
Published
2021-03-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K203154000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203154000KASILOF Cervical Plate SystemKahtnu Surgical, Inc.2020-11-05KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B644KCP14780PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-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. Non-sterile disposable devices associated with implantation may be included.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081208474
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B644KCP14810KASILOF Cervical Plate SystemKCP1-4812021-03-05
B644KCP14840KASILOF Cervical Plate SystemKCP1-4842021-03-05
B644KCP14870KASILOF Cervical Plate SystemKCP1-4872021-03-05
B644KCP14900KASILOF Cervical Plate SystemKCP1-4902021-03-05
B644KCP150900KASILOF Cervical Plate SystemKCP1-50902021-03-05
B644KCP150950KASILOF Cervical Plate SystemKCP1-50952021-03-05
B644KCP151000KASILOF Cervical Plate SystemKCP1-51002021-03-05
B644KCP151050KASILOF Cervical Plate SystemKCP1-51052021-03-05
B644KCP151100KASILOF Cervical Plate SystemKCP1-51102021-03-05
B644KCP11190KASILOF Cervical Plate SystemKCP1-1192018-09-01
B644KCP11210KASILOF Cervical Plate SystemKCP1-1212018-09-01
B644KCP11230KASILOF Cervical Plate SystemKCP1-1232018-09-01
B644KCP11250KASILOF Cervical Plate SystemKCP1-1252018-09-01
B644KCP11270KASILOF Cervical Plate SystemKCP1-1272018-09-01
B644KCP11290KASILOF Cervical Plate SystemKCP1-1292018-09-01
B644KCP11310KASILOF Cervical Plate SystemKCP1-1312018-09-01
B644KCP11330KASILOF Cervical Plate SystemKCP1-1332018-09-01
B644KCP11350KASILOF Cervical Plate SystemKCP1-1352018-09-01
B644KCP12350KASILOF Cervical Plate SystemKCP1-2352018-09-01
B644KCP12370KASILOF Cervical Plate SystemKCP1-2372018-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857596894OZARK Cervical Plate SystemVB Spine LLCKWQ2026-05-28
00840354204958Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204965Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204972Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204989Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204996Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205009Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205016Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205023Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205030Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205047Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205054Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205061Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205078Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205085Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205092Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205108Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205115Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205122Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205139Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205146Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205153Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205160Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205177Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205184Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205191Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205207Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354203654Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203661Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203678Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06