FDA.report

Instinct® Java™ System

Primary DI
00889024342156
Brand
Instinct® Java™ System
Company
ZIMMER SPINE
Model
046W1AN00560
Published
2016-06-16
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
MNHOrthosis, spondylolisthesis spinal fixation

Product Code Classifications

CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889024342156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024342156008890243421568890243421560889024342156

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(866)774-6368zimmer.consumerrelations@zimmer.com

Regulatory Flags

DUNS number
391738585
Device count
1
DM exempt
false
Premarket exempt
false
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

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00889024342644Universal Clamp ™SNA027-0-200002015-10-02
00889024342651Universal Clamp ™SNA027-0-200552015-10-20
00889024342668Universal Clamp ™SNA027-0-200602015-10-20
00889024342675Universal Clamp ™SNA027-0-300552015-10-20
00889024342682Universal Clamp ™SNA027-0-300602015-10-17
00889024342699Universal Clamp ™SNA027-0-300632015-10-20
00889024339750Universal Clamp™SN2027-1-021002016-06-17
00889024339767Universal Clamp™SN2027-1-021012016-06-17
00889024339774Universal Clamp™SN2027-1-021022016-06-17
00889024339781Universal Clamp™SN2027-1-021032016-06-17
00889024339798Universal Clamp™SN2027-1-021042016-06-17
00889024339804Universal Clamp™SN2027-1-021102016-06-17
00889024339811Universal Clamp™SN2027-1-021112016-06-17
00889024339828Universal Clamp™SN2027-1-021122016-06-17
00889024339835Universal Clamp™SN2027-1-021132016-06-17
00889024339842Universal Clamp™SN2027-1-022002016-06-17
00889024339859Universal Clamp™SN2027-1-022012016-06-17
00889024339866Universal Clamp™SN2027-1-022702016-06-17
00889024339873Universal Clamp™SN2027-1-022762016-06-17
00889024339880Universal Clamp™SN2027-1-025122016-06-17

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