FDA.reportPublic FDA data

K2M Fenestrated Tap System

Primary DI
10888857461291
Brand
K2M Fenestrated Tap System
Company
VB Spine LLC
Model
SP-4029-02
Catalog number
SP-4029-02
Device description
Tap, Fenestrated, Size Ø4.5
Published
2020-01-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KNWINSTRUMENT, BIOPSY
OARInjector, vertebroplasty (does not contain cement)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNWInstrument, BiopsyGastroenterology, Urology2
OARInjector, Vertebroplasty (Does Not Contain Cement)Orthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152872000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152872000K2M Fenestrated Tap SystemK2m2016-01-05KNW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888857461291PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088885746129110888857461291

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter4.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(703)777-3155mzellers@k2m.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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06937278630643CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630650CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630667CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630674CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630681CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630698CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630704CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630827CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630834CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630841CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630858CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630865CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630872CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630889CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630896CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630902CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630919CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278630926CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631046CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631053CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631060CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631077CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631084CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631091CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631107CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631114CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631121CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631138CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631145CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08
06937278631268CurawayZhejiang CuraWay Medical Technology Co., Ltd.KNW2026-08-08