FDA.reportPublic FDA data

VItal Spinal Fixation System

Primary DI
00887868528781
Brand
VItal Spinal Fixation System
Company
ZIMMER BIOMET INC
Model
850M0031
Device description
Cann Tower Palm Handle
Published
2024-06-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240539000Vital™ Spinal Fixation SystemZimvie Spine (Zimmer Biomet Spine, Inc.)2024-03-15NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868528781PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868528781008878685287818878685287810887868528781

GMDN Terms#

Term, Definition table
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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
045576443
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00888480511557Lineum®14-52505314-5250532020-07-07
00887868289163Virage® OCT07.01770.00107.01770.0012020-02-13
00887868289170Virage®07.01771.00207.01771.0022020-02-13
00887868289187Virage®07.01772.00207.01772.0022020-02-13
00887868289194Virage®07.01773.00207.01773.0022020-02-13
00887868289385Virage® OCT07.01803.00107.01803.0012020-02-13
00887868244728Vital™730M0011730M00112019-06-04
00887868244735Vital™730M0012730M00122019-06-04
03662663063081Vital Spinal Fixation System710M11562024-06-26
03662663063098Vital Spinal Fixation System710M12562024-06-26
03662663063104Vital Spinal Fixation System710M13562024-06-26
03662663063111Vital Spinal Fixation System710M14562024-06-26
03662663063128Vital Spinal Fixation System710M15562024-06-26
03662663063135Vital Spinal Fixation System710M17562024-06-26
00887868528774VItal Spinal Fixation System850M00302024-06-11
00887868528798VItal Spinal Fixation System850M00322024-06-11
00887868528804VItal Spinal Fixation System850M00332024-06-11
00887868528811VItal Spinal Fixation System850M00342024-06-11
00887868528828VItal Spinal Fixation System850M00352024-06-11
00887868528866VItal Spinal Fixation System850M00352024-06-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840311263882Streamline OCTXtant Medical Holdings, Inc.LXH2026-06-04
00198506091179ELMED INCORPORATEDELMED INCORPORATEDLXH2026-06-03
08698940967426SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03
08698940971454SayanSAYAN TIBBI ALETLER PAZARLAMA SANAYI VE TICARET LIMITED SIRKETILXH2026-06-03
G4533312BT0PEAK MEDICALPeak Medical Distribution Inc.LXH2026-06-03
07613327648355PANGEAStryker GmbHLXH2026-06-02
07613327648379PANGEAStryker GmbHLXH2026-06-02
00199150077359Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
00199150077366Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-06-01
00816127027215InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00816127027246InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00816127027253InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCLXH2026-06-01
00843511128777Omnia Medical TiBrid™-A/SAOMNIA MEDICAL, LLCLXH2026-06-01
00857915007712ObturatorA.M. SURGICAL, INC.LXH2026-06-01
00857915007729CannulaA.M. SURGICAL, INC.LXH2026-06-01
00857915007736RaspA.M. SURGICAL, INC.LXH2026-06-01
07899258648729Orthopedic InstrumentsGM DOS REIS INDUSTRIA E COMERCIO LTDALXH2026-06-01
B756007053002000Torque Wrench Adaptor HEX 3.5mmShukla MedicalLXH2026-06-01
10884450587727PowerCURVE®Merit Medical Systems, Inc.LXH2026-05-30
00818720013381SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-05-29
00843575124395Juveno™ Femoral Hip SystemB-ONE ORTHO, CORP.LXH2026-05-29
07630345728883Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542726170Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542753787Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542753794Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788833Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788840Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788857Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788864Surgical Manual InstrumentMedacta International SALXH2026-05-29
07630542788871Surgical Manual InstrumentMedacta International SALXH2026-05-29