FDA.reportPublic FDA data

NCB®

Primary DI
00889024483668
Brand
NCB®
Company
Zimmer GmbH
Model
47-2232-060-01
Catalog number
47-2232-060-01
Device description
NCB Cable Button for NCB Polyaxial Locking Plate, 2.5 mm Hex Drive
Published
2017-07-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone
HTNWASHER, BOLT NUT
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HTNWasher, Bolt NutOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120772000
K241754000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120772000NCB PERIPROSTHETIC TROCHANTER PLATES AND SCREWS, NCB CABLE BUTTON FOR NCB OPLYAXIAL LOCKING PLATEZimmer GmbH2012-06-12HRS
K241754000NCB® Polyaxial Locking Plate System; NCB® Periprosthetic Femur Plate System; NCB® Cable Button; NCB® Straight Narrow Shaft PlateZimmer Switzerland Manufacturing GmbH2024-08-15HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024483668PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024483668008890244836688890244836680889024483668

GMDN Terms#

Term, Definition table
TermDefinition
Implantable orthopaedic/craniofacial device connection screwA small implantable surgical device designed to join (connect) two components of an implanted orthopaedic and/or craniofacial device (e.g. osteotomy wedge to plate, femoral neck screw and plate); it is not intended to be screwed into the bone. It is typically made of metal and in the form of a short rod with machine threads at one end and a connecting slot (e.g., sunken Hex head) or thumbscrew at the other end.

Device Sizes#

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
488133448
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024289956NCB®02.00024.40102.00024.4012016-09-24
00889024289963NCB®02.00024.40202.00024.4022016-09-24
00889024289970NCB®-PP02.00024.41102.00024.4112016-09-24
00889024289987NCB®-PP02.00024.41202.00024.4122016-09-24
00889024289994NCB®-PP02.00024.41302.00024.4132016-09-24
00889024290006NCB®-PP02.00024.41402.00024.4142016-09-24
00889024292680NCB®02.02263.00902.02263.0092015-10-16
00889024292697NCB®02.02263.01202.02263.0122015-10-16
00889024292703NCB®02.02263.01502.02263.0152015-10-16
00889024292710NCB®02.02263.01802.02263.0182015-10-16
00889024292727NCB®02.02263.02102.02263.0212015-10-16
00889024292741NCB®02.02263.10902.02263.1092015-10-16
00889024292758NCB®02.02263.11202.02263.1122015-10-16
00889024292765NCB®02.02263.11502.02263.1152015-10-16
00889024292772NCB®02.02263.11802.02263.1182015-10-16
00889024292789NCB®02.02263.12102.02263.1212015-10-16
00889024292796NCB®02.02263.20102.02263.2012015-10-16
00889024292802NCB®02.02263.20202.02263.2022015-10-16
00889024292819NCB®02.02263.30102.02263.3012015-10-16
00889024292826NCB®02.02263.30202.02263.3022015-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053782783830TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783847TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783915TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783922TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783939TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783946TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783953TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783960TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782783977TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784134TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784141TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784158TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784165TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784172TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784189TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784264CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784271CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784288CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784295CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784301CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784318CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784325CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784523CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784530CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784547CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784554CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784561CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784578CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784585CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784592CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19