FDA.report

SPINE SYSTEM

Primary DI
00888480667698
Brand
SPINE SYSTEM
Company
BIOMET SPINE LLC
Model
8734-1006
Catalog number
8734-1006
Published
2018-01-26
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
GENFORCEPS, GENERAL & PLASTIC SURGERY

Product Code Classifications

CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00888480667698PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00888480667698008884806676988884806676980888480667698

GMDN Terms

TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. 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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
03662663063234Vital Spinal Fixation System727M54002024-05-10
03662663063241Vital Spinal Fixation System727M55102024-05-10
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

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190776417925MillenniumAvalign Technologies, Inc.GEN2026-03-23
00190776417963MillenniumAvalign Technologies, Inc.GEN2026-03-23
00190776418045MillenniumAvalign Technologies, Inc.GEN2026-03-23
00190776418052MillenniumAvalign Technologies, Inc.GEN2026-03-23
24026704941555PILLINGTELEFLEX INCORPORATEDGEN2026-03-23
24026704941562PILLINGTELEFLEX INCORPORATEDGEN2026-03-23
24026704941579PILLINGTELEFLEX INCORPORATEDGEN2026-03-23
24026704941609PILLINGTELEFLEX INCORPORATEDGEN2026-03-23
00192896122949Deluxe Alligator Grasping ForcepsSONTEC INSTRUMENTS, INC.GEN2026-03-19
04046826492632MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGEN2026-03-19
04046826492649MediconMedicon eG. Chirurgiemechaniker-GenossenschaftGEN2026-03-19
G453FA06160PEAK MEDICALPeak Medical Distribution Inc.GEN2026-03-19
00190776417703MillenniumAvalign Technologies, Inc.GEN2026-03-11
00190776417819MillenniumAvalign Technologies, Inc.GEN2026-03-11
00840329836924Black & Black SurgicalBLACK & BLACK SURGICAL, INC.GEN2026-03-05
04058749036152NAFehling Instruments GmbH & Co. KGGEN2026-03-05
00198506088667ELMED INCORPORATEDELMED INCORPORATEDGEN2026-02-25
00198506088674ELMED INCORPORATEDELMED INCORPORATEDGEN2026-02-25
00198506088872ELMED INCORPORATEDELMED INCORPORATEDGEN2026-02-25
00198506088476ELMED INCORPORATEDELMED INCORPORATEDGEN2026-02-23
00198506088742ELMED INCORPORATEDELMED INCORPORATEDGEN2026-02-23
00190776416713MillenniumAvalign Technologies, Inc.GEN2026-02-20
00810130207350MSIModern Surgical Instruments LLCGEN2026-02-20
B382SD6720680Surgical DirectSurgical Direct, Inc.GEN2026-02-17
B382SD6720690Surgical DirectSurgical Direct, Inc.GEN2026-02-17
00190776416508MillenniumAvalign Technologies, Inc.GEN2026-02-16
B382SD49129280Surgical DirectSurgical Direct, Inc.GEN2026-02-16
B382SD6522210Surgical DirectSurgical Direct, Inc.GEN2026-02-16
B382SD6536480Surgical DirectSurgical Direct, Inc.GEN2026-02-16
03662663129046Lineum Occipito-Cervico-Thoracic (OCT) Spinal Fixation SystemHighridge Medical, LLCGEN2026-02-11