FDA.reportPublic FDA data

Zimmer® Natural Nail™ System

Primary DI
00889024298569
Brand
Zimmer® Natural Nail™ System
Company
Zimmer GmbH
Model
47-2490-046-43
Catalog number
47-2490-046-43
Device description
CALIBRATED DRILL 4.3 MM - ASIA
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120715000
K231114000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120715000ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY FEMORAL NAIL - ASIA SHORTZimmer GmbH2012-08-10HSB
K231114000Zimmer® Natural Nail® System Cephalomedullary Nails; Affixus® Natural Nail® Humeral Nail SystemZimmer Switzerland Manufacturing GmbH2023-08-09HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024298569PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024298569008890242985698890242985690889024298569

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, single-use, sterileA sterile shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter4.3Millimeter

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmer.com
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
488133448
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

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
00817867021044PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021051PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021068PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021075PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021082PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021099PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021105PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021112PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021129PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021136PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021143PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021150PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021167PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021174PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021181PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021198PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021204PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021211PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021228PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021235PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021242PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021259PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021266PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021273PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021280PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021297PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021303PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021310PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021327PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01
00817867021334PNP FemurORTHOPEDIATRICS CORP.HSB2026-10-01