FDA.reportPublic FDA data

Zimmer Biomet Universal Navigation System

Primary DI
00887868346255
Brand
Zimmer Biomet Universal Navigation System
Company
BIOMET SPINE LLC
Model
130T0007
Catalog number
130T0007
Published
2019-12-13
Public version status
New
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
OLOOrthopedic stereotaxic instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868346255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868346255008878683462558878683462550887868346255

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(800)447-3625USBROCustomerService@zimmerbiomet.com
+1(866)774-6368zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
018577570
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
03662663063234Vital Spinal Fixation System727M54002024-05-10
03662663063241Vital Spinal Fixation System727M55102024-05-10
03662663063258Vital Spinal Fixation System727M64002024-05-10
03662663063265Vital Spinal Fixation System727M65102024-05-10
03662663063272Vital Spinal Fixation System727M74002024-05-10
03662663063289Vital Spinal Fixation System727M75102024-05-10
03662663063296Vital Spinal Fixation System727M84002024-05-10
03662663063302Vital Spinal Fixation System727M85102024-05-10
03662663063524Vital Spinal Fixation System727M54012024-05-10
03662663063531Vital Spinal Fixation System727M54022024-05-10
03662663063548Vital Spinal Fixation System727M55112024-05-10
03662663063555Vital Spinal Fixation System727M55122024-05-10
03662663063562Vital Spinal Fixation System727M64012024-05-10
03662663063579Vital Spinal Fixation System727M64022024-05-10
03662663063586Vital Spinal Fixation System727M65112024-05-10
03662663063593Vital Spinal Fixation System727M65122024-05-10
03662663063609Vital Spinal Fixation System727M74012024-05-10
03662663063616Vital Spinal Fixation System727M74022024-05-10
03662663063623Vital Spinal Fixation System727M75112024-05-10
03662663063630Vital Spinal Fixation System727M75122024-05-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00193982622312EXCELSIUSGPSGLOBUS MEDICAL, INC.OLO2026-03-24
00193982622329EXCELSIUSGPSGLOBUS MEDICAL, INC.OLO2026-03-24
00199150024469INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-03-22
00199150024483INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-03-22
00199150038138INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.OLO2026-03-21
00885556919712Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919729Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919743Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919750Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919767Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556919774Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924198Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924204Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924211Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924228Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924235Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924242Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924266Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924273Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
00885556924297Real IntelligenceSmith & Nephew, Inc.OLO2026-03-10
20885556924307NASmith & Nephew, Inc.OLO2026-03-10
07613327627725MakoMAKO SURGICAL CORP.OLO2026-03-10
00840493413228RIVA Posterior Fixation SystemXENIX MEDICAL LLCOLO2026-03-03
07613327683653Shoulder 1.5 Installation DiskMAKO SURGICAL CORP.OLO2026-03-03
10888857563384Q Interbody InstrumentsK2M, INC.OLO2026-03-03
10888857563391Q Interbody InstrumentsK2M, INC.OLO2026-03-03
10888857563407Q Interbody InstrumentsK2M, INC.OLO2026-03-03
10888857563414Q Interbody InstrumentsK2M, INC.OLO2026-03-03
10888857563421Q Interbody InstrumentsK2M, INC.OLO2026-03-03
10888857578876Q Interbody InstrumentsK2M, INC.OLO2026-03-03