FDA.reportPublic FDA data

King Cobra

Primary DI
B014KCP201
Brand
King Cobra
Company
EMINENT SPINE LLC
Model
KCP201
Published
2017-02-09
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
K103068000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103068000KING COBRA ANTERIOR CERVICAL PLATEEminent Spine2011-01-14KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B014KCP201PrimaryHIBCC0

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
022576742
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B014DB100DiamondbackDB1002017-02-08
B014DB1030DiamondbackDB10302017-02-08
B014DB1035DiamondbackDB10352017-02-08
B014DB1040DiamondbackDB10402017-02-08
B014DB1045DiamondbackDB10452017-02-08
B014DB1050DiamondbackDB10502017-02-08
B014DB1055DiamondbackDB10552017-02-08
B014DB1060DiamondbackDB10602017-02-08
B014DB1065DiamondbackDB10652017-02-08
B014DB1070DiamondbackDB10702017-02-08
B014DB1075DiamondbackDB10752017-02-08
B014DB1080DiamondbackDB10802017-02-08
B014DB1085DiamondbackDB10852017-02-08
B014DB1090DiamondbackDB10902017-02-08
B014DB1095DiamondbackDB10952017-02-08
B014DB1100DiamondbackDB11002017-02-08
B014DB1110DiamondbackDB11102017-02-08
B014DB1120DiamondbackDB11202017-02-08
B014DB1130DiamondbackDB11302017-02-08
B014DB1140DiamondbackDB11402017-02-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
00840311263080Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263097Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263103Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263110Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263127Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263134Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263141Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263158Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263165Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263172Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263189Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263196Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263202Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263219Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263226Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263233Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263240Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263257Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263264Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263271Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263288Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263295Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263301Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263318Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263325Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02
00840311263332Streamline TL Spinal Fixation SystemXtant Medical Holdings, Inc.KWQ2026-06-02