FDA.reportPublic FDA data

N/A

Primary DI
00889024179028
Brand
N/A
Company
Zimmer, Inc.
Model
9354-20-002
Published
2017-01-25
Public version status
Update
Distribution status
Not 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
HTOREAMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024179028PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024179028008890241790288890241790280889024179028

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument designed to resect (cut out part of the bone) and precisely shape a specific area of bone for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). It is commonly called a mill or a reamer and is typically designed as either a preshaped or a solid cylindrical body with an end or circumferential cutting edge. It is attached to a shaft for manual or powered rotation and may be steered over a guide or spigot that has been inserted into the site to control the cutting action. It is typically made of a high-grade stainless steel alloy in varying sizes. This is a reusable device.

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@zimmer.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
00887868582158Affixus®Zimmer, Inc.HTO2026-03-19
03662663136693Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHTO2026-03-17
03662663136709Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHTO2026-03-17
03662663136723Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHTO2026-03-17
00888867531659Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531666Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531673Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531697Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531703Arthrex®ARTHREX, INC.HTO2026-03-16
00888867531710Arthrex®ARTHREX, INC.HTO2026-03-16
00843575120205Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120212Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120229Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120236Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120243Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120250Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120267Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00843575120274Primo™ Acetabular SystemB-ONE ORTHO, CORP.HTO2026-02-11
00841731134707Hintermann Series VILEX LLCHTO2026-01-16
04026575281701MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHTO2026-01-06
04026575285914MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHTO2026-01-06
04026575288304MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHTO2026-01-06
04026575288342MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHTO2026-01-06
04026575288380MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHTO2026-01-06
04026575288427MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHTO2026-01-06
04026575288465MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHTO2026-01-06
04026575288489MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHTO2026-01-06
04026575288502MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHTO2026-01-06
04026575288519MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHTO2026-01-06
04026575288533MP Reconstruction SystemWALDEMAR LINK GmbH & Co. KGHTO2026-01-06