FDA.reportPublic FDA data

Zimmer® DTO®

Primary DI
00889024284456
Brand
Zimmer® DTO®
Company
Zimmer GmbH
Model
01.03799.058
Device description
Zimmer® DTO® Pin press
Published
2016-08-29
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
NQPPOSTERIOR METAL/POLYMER SPINAL SYSTEM, FUSION

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NQPPosterior Metal/Polymer Spinal System, FusionOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101704000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101704000ZIMMER DTO PIN PRESS INSTRUMENTZimmer Spine, Inc.2010-08-18NQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024284456PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024284456008890242844568890242844560889024284456

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.

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
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00613994123732CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123749CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123800CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123824CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123831CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123909CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123916CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
00613994123923CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NQP2015-09-17
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