FDA.report

NA

Primary DI
00889024460331
Brand
NA
Company
Zimmer, Inc.
Model
51-1170-13-21
Published
2016-07-26
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

Related Records

Contact Domains

Product Codes

CodeName
HTRRASP

Product Code Classifications

CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889024460331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024460331008890244603318890244603310889024460331

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0
Length170Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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

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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

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10889981443368SpecialsSeaspine Orthopedics CorporationHTR2026-03-03
00190776416690MillenniumAvalign Technologies, Inc.HTR2026-02-16
03662663109574Mergence-A Preparation InstrumentationHighridge Medical, LLCHTR2026-02-11
00190376538969Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTR2026-02-10
00190376538976Intervertebral Disc Preparation InstrumentsALPHATEC SPINE, INC.HTR2026-02-10
03662663083720ActivLHighridge Medical, LLCHTR2026-02-03
03662663083737ActivLHighridge Medical, LLCHTR2026-02-03
03662663083744ActivLHighridge Medical, LLCHTR2026-02-03
00889024705524Identity 40MM Inset Humeral ProtectorZimmer, Inc.HTR2026-01-16
00840180543955General InstrumentsALPHATEC SPINE, INC.HTR2025-12-31
00840180545058General InstrumentsALPHATEC SPINE, INC.HTR2025-12-31
00888480490289Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490296Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490302Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
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00888480490357Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490364Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490371Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
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00888480490395Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490401Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490418Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490425Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490432Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29
00888480490449Solitaire Cervical Spacer SystemHighridge Medical, LLCHTR2025-12-29