FDA.report

Instinct™ Java® System

Primary DI
00889024340992
Brand
Instinct™ Java® System
Company
ZIMMER SPINE
Model
046W0AN45525
Published
2017-05-24
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
true

Related Records

Contact Domains

Product Codes

CodeName
MNHOrthosis, spondylolisthesis spinal fixation

Product Code Classifications

CodeDeviceSpecialtyClass
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889024340992PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024340992008890243409928890243409920889024340992

GMDN Terms

TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Length25Millimeter

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

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

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00763000992033MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-03-14
00841732108134RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
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00841732145092RAPHAEL Pedicle Screw SystemCTL MEDICAL CORPORATIONMNH2024-01-04
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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