FDA.report

Vitality®+ Osteotomy

Primary DI
00880304907898
Brand
Vitality®+ Osteotomy
Company
BIOMET SPINE LLC
Model
700M3100
Catalog number
700M3100
Published
2018-06-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
FSMTRAY, SURGICAL, INSTRUMENT
LRPTRAY, SURGICAL

Product Code Classifications

CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1
LRPTray, SurgicalGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00880304907898PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304907898008803049078988803049078980880304907898

GMDN Terms

TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable device.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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
true
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

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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

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00888118150264PURE PECTUSKLS-Martin L.P.FSM2026-05-25
00888118150448IXOSKLS-Martin L.P.FSM2026-05-25
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00888118150462IXOSKLS-Martin L.P.FSM2026-05-25
00888118150479IXOSKLS-Martin L.P.FSM2026-05-25
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00888118153050IXOSKLS-Martin L.P.FSM2026-05-25
00888118153067IXOSKLS-Martin L.P.FSM2026-05-25
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00888118153081IXOSKLS-Martin L.P.FSM2026-05-25
00888118154613LEVEL ONEKLS-Martin L.P.FSM2026-05-25
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