FDA.reportPublic FDA data

NCB®

Primary DI
00889024289956
Brand
NCB®
Company
Zimmer GmbH
Model
02.00024.401
Catalog number
02.00024.401
Device description
Shaft plate, provisional, straight, narrow, 8/10/12
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113718000
K241754000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113718000NCB STRAIGHT NARROW SHAFT PLATESZimmer GmbH2012-01-27HRS
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
00889024289956PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024289956008890242899568890242899560889024289956

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

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
true
Expiration date on label
false
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
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
00889024292833NCB®02.02264.00902.02264.0092015-10-16

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
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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
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08053782784172TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784189TITANIUM SCREWBRM EXTREMITIES SRLHWC2026-10-19
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08053782784271CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784288CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784295CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784301CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
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08053782784547CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784554CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
08053782784561CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19
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08053782784592CHAMFERED SCREWBRM EXTREMITIES SRLHWC2026-10-19