FDA.reportPublic FDA data

Vitality®

Primary DI
00880304988712
Brand
Vitality®
Company
BIOMET SPINE LLC
Model
730M3095
Catalog number
730M3095
Published
2017-12-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWQAppliance, fixation, spinal intervertebral body
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304988712PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304988712008803049887128803049887120880304988712

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. 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

Regulatory Flags#

DUNS number
018577570
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00880304860544Vitality®+ Osteotomy732M2129732M21292018-06-05
00880304860551Vitality®+ Osteotomy732M2221732M22212018-06-05
00880304860568Vitality®+ Osteotomy732M2224732M22242018-06-05
00880304860575Vitality®+ Osteotomy732M2226732M22262018-06-05
00880304860582Vitality®+ Osteotomy732M2229732M22292018-06-05
00888480489450LINEUM OCT SPINE SYSTEM14-52501314-5250132020-10-15
00888480511564LINEUM OCT SPINE SYSTEM14-52505414-5250542020-07-07
00888480207542POLARIS 5.5 SPINAL SYSTEM2000-23252000-23252015-10-24
00880304964143Polaris™ 6.35 Spinal System14-513730R14-513730R2020-11-10
00880304964433Polaris™ 6.35 Spinal System14-513555R14-513555R2020-11-10
03662663058155Spine System14-50077114-5007712021-12-17
03662663058162Spine System14-50077214-5007722021-12-17
03662663058179Spine System14-50077314-5007732021-12-17
03662663058186Spine System14-50077414-5007742021-12-17
03662663058193Spine System14-50077514-5007752021-12-17
03662663058209Spine System14-50077614-5007762021-12-17
03662663058216Spine System14-50077714-5007772021-12-17
03662663058223Spine System14-50077814-5007782021-12-17
03662663058230Spine System14-50077914-5007792021-12-17
03662663058247Spine System14-50078014-5007802021-12-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613153045670XIA IStryker CorporationNKB2014-12-08
07613153045700XIA IStryker CorporationKWQ2014-12-08
07613153045717XIA IStryker CorporationNKB2014-12-08
07613153045724XIA IStryker CorporationNKB2014-12-08
07613153045724XIA IStryker CorporationKWQ2014-12-08
07613153045731XIA IStryker CorporationKWQ2014-12-08
07613153045748XIA IStryker CorporationNKB2014-12-08
07613153045748XIA IStryker CorporationKWQ2014-12-08
07613153045755XIA IStryker CorporationKWQ2014-12-08
07613153045755XIA IStryker CorporationNKB2014-12-08
07613153045762XIA IIStryker CorporationKWQ2014-12-08
07613153045762XIA IIStryker CorporationNKB2014-12-08
07613153045793XIA IIStryker CorporationKWQ2014-12-08
07613153045847XIA IIStryker CorporationNKB2014-12-08
07613153045854XIA IIStryker CorporationNKB2014-12-08
07613153045854XIA IIStryker CorporationKWQ2014-12-08
07613153045861XIA IIStryker CorporationNKB2014-12-08
07613153045878XIA IIStryker CorporationKWQ2014-12-08
07613153045885XIA IIStryker CorporationNKB2014-12-08
07613153045885XIA IIStryker CorporationKWQ2014-12-08
07613153045892XIA IIStryker CorporationKWQ2014-12-08
07613153045892XIA IIStryker CorporationNKB2014-12-08
07613153045908XIA IIStryker CorporationKWQ2014-12-08
07613153045908XIA IIStryker CorporationNKB2014-12-08
07613153045915XIA IIStryker CorporationKWQ2014-12-08
07613153045915XIA IIStryker CorporationNKB2014-12-08
07613153045922XIA IIStryker CorporationNKB2014-12-08