FDA.reportPublic FDA data

Instinct® Java™ System

Primary DI
00889024342248
Brand
Instinct® Java™ System
Company
ZIMMER SPINE
Model
046W1AN00700
Published
2016-06-17
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
MNHOrthosis, spondylolisthesis spinal fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024342248PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024342248008890243422488890243422480889024342248

GMDN Terms#

Term, Definition table
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.

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(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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07290115935615Counter Torque STPREMIA SPINE LTDMNH2026-05-25
00763000887070CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-16
00763000887155CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-16
00763000992033MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-14
00841732108134RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108141RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108158RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108165RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108172RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108189RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108196RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108202RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108219RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732108226RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732122529RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732122536RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732131835RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732145085RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732145092RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
00841732117860PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00841732117877PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00841732117884PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00841732117891PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00841732117907PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00841732117914PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2023-09-07
00840996188715THUNDERBOLT Minimally Invasive Pedicle Screw SystemsChoice Spine, LPMNH2023-02-03
088000333584424CIS VANE SPINE SYSTEMALPHANOX CO.,LTD.MNH2018-08-17
00841732118959PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2017-08-08
00841732118966PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2017-08-08
00841732118973PICASSO II MIS Spinal SystemCTL Medical CorporationMNH2017-08-08