FDA.report

Instinct® Java™ System

Primary DI
00889024342255
Brand
Instinct® Java™ System
Company
ZIMMER SPINE
Model
046W1AN00701
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

Related Records

Contact Domains

Product Codes

CodeName
MNIORTHOSIS, SPINAL PEDICLE FIXATION

Product Code Classifications

CodeDeviceSpecialtyClass
MNIOrthosis, Spinal Pedicle FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889024342255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024342255008890243422558890243422550889024342255

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

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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00763000887179CD HORIZON® Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-03-16
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00841732117884PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2023-09-07
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00841732119017PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732119024PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732119031PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732119048PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732119055PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
00841732119062PICASSO II MIS Spinal SystemCTL Medical CorporationMNI2017-08-08
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