FDA.reportPublic FDA data

Vital™

Primary DI
00887868244728
Brand
Vital™
Company
ZIMMER BIOMET INC
Model
730M0011
Catalog number
730M0011
Published
2019-06-04
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
HXWBender
NKBThoracolumbosacral Pedicle Screw System

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HXWBenderOrthopedic1
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183550000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183550000Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2019-04-08NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868244728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868244728008878682447288878682447280887868244728

GMDN Terms#

Term, Definition table
TermDefinition
Manual orthopaedic bender, reusableA manually-operated surgical instrument designed to bend orthopaedic devices, typically those for implantation (e.g., orthopaedic rods, bone fixation plates), to an appropriate anatomical shape. The bending process is typically performed within the operating room (OR), inside or outside of the operative sterile field. The device may be hand held or table mounted. This is a reusable device.

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
045576443
Device count
1
Premarket exempt
true
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
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
00887868528781VItal Spinal Fixation System850M00312024-06-11
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
00763000891428CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-09-20
00763000891480CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-09-20
00197157116712ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116729ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116736ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116743ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116750ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116767ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116774ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116781ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116798ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116804ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116811ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116828ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116835ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116842ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116859ZAVATION SCREWZavation LLCNKB2026-09-18
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00197157116897ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116903ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116910ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116927ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116934ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116941ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116958ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116965ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116972ZAVATION SCREWZavation LLCNKB2026-09-18
00197157116989ZAVATION SCREWZavation LLCNKB2026-09-18