FDA.reportPublic FDA data

NA

Primary DI
00889024111493
Brand
NA
Company
Zimmer GmbH
Model
502015650
Device description
Drill 3.2x145mm AO
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K123347000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123347000NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0Normed Medizin-Technik GmbH2013-08-02HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024111493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024111493008890241114938890241114930889024111493

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
Length145Millimeter
Outer Diameter3.2Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
488133448
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868453120Avenir®01.08000.01201.08000.0122021-02-25
00889024298521Natural Nail®47-2487-002-0047-2487-002-002015-10-21
00889024298538Natural Nail®47-2487-002-0547-2487-002-052015-10-21
00889024298545Natural Nail®47-2487-002-1047-2487-002-102015-10-21
00889024298552Natural Nail®47-2487-002-1547-2487-002-152015-10-21
00889024292512NCB®02.02261.0132024-05-03
00889024292550NCB®02.02261.1132024-05-03
00889024296558NCB®02.03156.0902024-05-03
00889024296565NCB®02.03156.0952024-05-03
00889024296572NCB®02.03156.1002024-05-03
00889024506503Affixus® Natural Nail®1100356641100356642019-03-21
00889024506510Affixus® Natural Nail®1100372371100372372019-03-21
00889024506527Affixus® Natural Nail®1100356651100356652019-03-21
00889024506534Affixus® Natural Nail®1100356661100356662019-03-21
00889024506558Affixus® Natural Nail®1100356681100356682019-03-21
00889024277038Dynesys® Top-Loading System01.03956.4502015-10-16
00889024283688Dynesys®01.03710.0062015-10-16
00889024283695Dynesys®01.03710.6452016-03-14
00889024283701Dynesys®01.03711.1002016-03-14
00889024283718Dynesys®01.03711.2002016-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556819845Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819852Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819869Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819876Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819883Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819890Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819906Uni-CP Compression PlateSmith & Nephew, Inc.HRS2023-11-07
00885556819722Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819746Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819760Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-26
00885556819807UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-26
00885556819814UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-26
00885556819821UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-26
00885556819838UNI-CP Compression PlateSmith & Nephew, Inc.HRS2023-10-26
00885556819623Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-25
00885556819647SURFIXTotal Wrist FusionSmith & Nephew, Inc.HRS2023-10-25
00885556819661Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-25
00885556819685Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-25
00885556819708Total Wrist FusionSmith & Nephew, Inc.HRS2023-10-25
00885556838303Total Foot System 2Smith & Nephew, Inc.HWC2023-04-25
00885556838303Total Foot System 2Smith & Nephew, Inc.HRS2023-04-25
00885556838327Total Foot System 2Smith & Nephew, Inc.HWC2023-04-18
00885556838327Total Foot System 2Smith & Nephew, Inc.HRS2023-04-18
00885556824764DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824771DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824788DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824795DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824818DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824825DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556835043Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22