FDA.reportPublic FDA data

NA

Primary DI
00889024061002
Brand
NA
Company
Zimmer, Inc.
Model
2360-153-27
Catalog number
00-2360-153-27
Published
2016-07-27
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
HWXTAP, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024061002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024061002008890240610028890240610020889024061002

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
056038268
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868150876Affixus®8151113008151113002026-03-20
00887868150333Affixus®8151103008151103002026-03-19
00887868150340Affixus®8151103208151103202026-03-19
00887868150357Affixus®8151103408151103402026-03-19
00887868150364Affixus®8151103608151103602026-03-19
00887868150371Affixus®8151103808151103802026-03-19
00887868150388Affixus®8151104008151104002026-03-19
00887868150395Affixus®8151104208151104202026-03-19
00887868150401Affixus®8151114208151114202026-03-19
00887868150555Affixus®8151123008151123002026-03-19
00887868150562Affixus®8151123208151123202026-03-19
00887868150579Affixus®8151123408151123402026-03-19
00887868150586Affixus®8151123608151123602026-03-19
00887868150593Affixus®8151123808151123802026-03-19
00887868150609Affixus®8151124008151124002026-03-19
00887868150616Affixus®8151124208151124202026-03-19
00887868150883Affixus®8151113208151113202026-03-19
00887868150890Affixus®8151113408151113402026-03-19
00887868150906Affixus®8151113608151113602026-03-19
00887868150913Affixus®8151113808151113802026-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G832F00503450ACURA Stabilization SystemBioalign Inc.HWX2026-03-09
G832F00503550ACURA Stabilization SystemBioalign Inc.HWX2026-03-09
G832F00503650ACURA Stabilization SystemBioalign Inc.HWX2026-03-09
03662663131674Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131681Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131698Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131704Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131711Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131728Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131735Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131803Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131810Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131827Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131834Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
10886982351661NASynthes GmbHHWX2026-02-11
10886982351678NASynthes GmbHHWX2026-02-11
00810112597417TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHWX2026-02-10
00810112597424TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHWX2026-02-10
00810112597431TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHWX2026-02-10
07640177821324Neo Medical Pedicle screw kitNeo Medical SAHWX2026-02-09
00199150055296Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-26
00199150055227Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055234Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055241Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055258Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055265Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055272Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055289Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055302Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055319Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25