FDA.reportPublic FDA data

NCB®

Primary DI
00889024292710
Brand
NCB®
Company
Zimmer GmbH
Model
02.02263.018
Catalog number
02.02263.018
Device description
NCB periprosthetic femur plate, proximal, right, 18 holes, 363 mm
Published
2015-10-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

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
K100111000
K241754000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100111000NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEMZimmer, Inc.2010-04-12HRS
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
00889024292710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024292710008890242927108890242927100889024292710

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

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
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
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
08809986482594CastleLoc Pectus Bar SystemL&K BIOMED CO. ,LTD.HRS2026-10-23
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00810112599176TriLEAPSynthes GmbHHWC2025-03-17
00810112599176TriLEAPSynthes GmbHHRS2025-03-17
00810112599183TriLEAPSynthes GmbHHWC2025-03-17
00810112599183TriLEAPSynthes GmbHHRS2025-03-17
00810112599190TriLEAPSynthes GmbHHWC2025-03-17
00810112599190TriLEAPSynthes GmbHHRS2025-03-17
00810112599206TriLEAPSynthes GmbHHWC2025-03-17
00810112599206TriLEAPSynthes GmbHHRS2025-03-17
00810112599213TriLEAPSynthes GmbHHRS2025-03-17
00810112599213TriLEAPSynthes GmbHHWC2025-03-17
00810112599220TriLEAPSynthes GmbHHWC2025-03-17
00810112599220TriLEAPSynthes GmbHHRS2025-03-17
00810112599237TriLEAPSynthes GmbHHWC2025-03-17
00810112599237TriLEAPSynthes GmbHHRS2025-03-17
00810112599244TriLEAPSynthes GmbHHWC2025-03-17
00810112599244TriLEAPSynthes GmbHHRS2025-03-17
00810112599251TriLEAPSynthes GmbHHWC2025-03-17
00810112599251TriLEAPSynthes GmbHHRS2025-03-17
00810112599268TriLEAPSynthes GmbHHWC2025-03-17
00810112599268TriLEAPSynthes GmbHHRS2025-03-17
00810112592245TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592245TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592252TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-23
00810112592252TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592429TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23