FDA.reportPublic FDA data

KASILOF Cervical Plate System

Primary DI
B644KCP11250
Brand
KASILOF Cervical Plate System
Company
KAHTNU SURGICAL
Model
KCP1-125
Device description
KASILOF Cervical Plate 1 Level 25mm
Published
2018-09-01
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
K173867000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173867000Axis Anterior Cervical Plate SystemAxis Orthopaedics2018-04-05KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B644KCP11250PrimaryHIBCC0

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
B644KCP14780KASILOF Cervical Plate SystemKCP1-4782021-03-05
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
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
00810017915125SABER-XA, Screw Ø5.0 x 22.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915149SABER-XA, Screw Ø5.0 x 32.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915156SABER-XA, Screw Ø5.5 x 22.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915163SABER-XA, Screw Ø5.5 x 27.5ELEVATION SPINE, INC.KWQ2026-09-22
00810017915170SABER-XA, Screw Ø5.5 x 32.5ELEVATION SPINE, INC.KWQ2026-09-22
00613994568311TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2015-08-05
00613994568823TSRH® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2015-08-05
04546540147257XIA IIStryker CorporationKWQ2014-12-08
04546540147769XIA IIStryker CorporationKWQ2014-12-08
04546540147806XIA IIStryker CorporationKWQ2014-12-08
04546540147905XIA IIStryker CorporationKWQ2014-12-08
04546540147912XIA IStryker CorporationKWQ2014-12-08
04546540147929XIA IStryker CorporationKWQ2014-12-08
04546540147936XIA IStryker CorporationKWQ2014-12-08
04546540147974XIA IStryker CorporationKWQ2014-12-08
04546540147981XIA IStryker CorporationKWQ2014-12-08
04546540147998XIA IStryker CorporationKWQ2014-12-08
04546540148001XIA IIStryker CorporationKWQ2014-12-08
04546540148018XIA IIStryker CorporationKWQ2014-12-08
04546540148025XIA IIStryker CorporationKWQ2014-12-08
04546540148735XIA IIStryker CorporationKWQ2014-12-08
04546540148742XIA IIStryker CorporationKWQ2014-12-08
04546540148759XIA IIStryker CorporationKWQ2014-12-08
04546540148766XIA IIStryker CorporationKWQ2014-12-08
04546540148773XIA IIStryker CorporationKWQ2014-12-08
04546540148780XIA IIStryker CorporationKWQ2014-12-08
04546540148797XIA IIStryker CorporationKWQ2014-12-08
04546540148803XIA IIStryker CorporationKWQ2014-12-08
04546540148810XIA IIStryker CorporationKWQ2014-12-08
04546540148827XIA IIStryker CorporationKWQ2014-12-08