FDA.reportPublic FDA data

NA

Primary DI
00889024065017
Brand
NA
Company
Zimmer, Inc.
Model
2882-00-02
Published
2016-07-27
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
FZOCHISEL, SURGICAL, MANUAL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZOChisel, Surgical, ManualGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024065017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024065017008890240650178890240650170889024065017

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@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
04052536017546tezoUlrich GmbH & Co. KGFZO2026-03-12
00190776417598MillenniumAvalign Technologies, Inc.FZO2026-03-04
00190776417604MillenniumAvalign Technologies, Inc.FZO2026-03-04
03662663109215Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFZO2026-02-11
03662663109222Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLCFZO2026-02-11
04058749067538NAFehling Instruments GmbH & Co. KGFZO2026-01-28
04058749075991NAFehling Instruments GmbH & Co. KGFZO2026-01-28
00190776415280MillenniumAvalign Technologies, Inc.FZO2026-01-27
00889024703872Offset Box OsteotomeZimmer, Inc.FZO2025-12-18
03662663271349Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271356Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271363Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271370Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271394Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271400Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271417Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271431Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271455Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271462Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271479Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271493Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271509Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271516Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271523Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271530Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271547Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271554Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271561Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271578Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18
03662663271585Timberline Lateral Fusion SystemHighridge Medical, LLCFZO2025-12-18