FDA.reportPublic FDA data

Omnia Medical VBR

Primary DI
08435111000519
Brand
Omnia Medical VBR
Company
OMNIA MEDICAL, LLC
Model
06-5V-TAM2
Catalog number
06-5V-TAM2
Device description
Omnia Medical VBR, 12mm Tamp
Published
2019-07-02
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
MQPSpinal Vertebral Body Replacement Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172323000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172323000Omnia Medical VBROmnia Medical, LLC2017-10-26MQP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08435111000519PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08435111000519084351110005198435111000519

GMDN Terms#

Term, Definition table
TermDefinition
Surgical tampA hand-held, surgical instrument used to pack tissue or other material during a surgical intervention. It typically consists of a shaft that terminates in a blunt (flat or profiled) tip at the distal end and a handle at the proximal end. It is typically a one-piece instrument made of high-grade stainless steel, but some types may employ a synthetic material for the handle (e.g., Tufnol). The surgeon may pack the material by applying hand pressure or by tapping the proximal end with a hammer/mallet. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
3044134851customerservice@omniamedical.com

Regulatory Flags#

DUNS number
079467378
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
00843511128777Omnia Medical TiBrid™-A/SA14-5A-QAT114-5A-QAT12026-06-01
00843511128388Omnia Medical TiBrid™- A/SA 17-5A-BL0617-5A-BL062026-05-11
00843511128395Omnia Medical TiBrid™- A/SA 17-5A-BL082026-05-11
00843511128401Omnia Medical TiBrid™- A/SA 17-5A-BL102026-05-11
00843511128418Omnia Medical TiBrid™- A/SA 17-5A-BL122026-05-11
00843511128425Omnia Medical TiBrid™- A/SA 17-5A-BL142026-05-11
00843511128432Omnia Medical TiBrid™- A/SA 17-5A-BL162026-05-11
00843511128463Omnia Medical TiBrid™- A/SA 17-5A-AWL1-B2026-05-11
00843511128494Omnia Medical TiBrid™-C07-5C-LTDE2026-05-11
00843511128500Omnia Medical Instruments99-5A-CL132026-05-11
00843511128517Omnia Medical Instruments99-5A-CL202026-05-11
00843511128548Omnia Medical Golden Spike OM-TLS4015-T2026-05-11
00843511128555Omnia Medical Golden Spike OM-TLS4016-T2026-05-11
00843511128562Omnia Medical Golden Spike OM-TLS4017-T2026-05-11
00843511128579Omnia Medical Golden Spike OM-TLS4018-T2026-05-11
00843511128586Omnia Medical Golden Spike OM-TLS4019-T2026-05-11
00843511128593Omnia Medical Golden Spike OM-TLS4020-T2026-05-11
00843511128609Omnia Medical Golden Spike OM-TLS4021-T2026-05-11
00843511128616Omnia Medical Golden Spike OM-TLS4022-T2026-05-11
00843511128623Omnia Medical Golden Spike OM-TLS4023-T2026-05-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840283403460LumiVy™VY SPINE LLCMQP2026-06-05
00763000857844T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-01
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00763000857998T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-06-01
07640172551103KONG-TL VBR System, Expansion Handleicotec AGMQP2020-06-19
07640172551110KONG-TL VBR System, Locking Rodicotec AGMQP2020-06-19
08033726407923DSCSINTEA PLUSTEK SRLMQP2015-10-16
08033726404250DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726404267DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407664DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407671DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407701DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407718DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407725DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407732DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407749DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407756DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407763DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407770DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407787DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407794DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407800DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407817DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407824DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407831DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407848DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407855DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407862DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407879DSCSINTEA PLUSTEK SRLMQP2015-10-09
08033726407886DSCSINTEA PLUSTEK SRLMQP2015-10-09