FDA.reportPublic FDA data

SPINE SYSTEM

Primary DI
00888480667636
Brand
SPINE SYSTEM
Company
BIOMET SPINE LLC
Model
8734-1000
Catalog number
8734-1000
Published
2018-01-26
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
GENFORCEPS, GENERAL & PLASTIC SURGERY

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GENForceps, General & Plastic SurgeryGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888480667636PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888480667636008884806676368884806676360888480667636

GMDN Terms#

Term, Definition table
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#

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
Premarket exempt
true
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00724995268985Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995268992Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269005Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269012Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269029Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269036Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
00724995269043Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-25
B35665124160American MedicalsAmerican MedicalsGEN2026-09-25
00724995266752Snowden-PencerSTERIS Deutschland GmbHGEN2026-09-24
00190776431273MillenniumAvalign Technologies, Inc.GEN2026-09-22
00190776432096MillenniumAvalign Technologies, Inc.GEN2026-09-22
04058749037364NAFehling Instruments GmbH & Co. KGGEN2026-09-21
00190776431006MillenniumAvalign Technologies, Inc.GEN2026-09-18
00190776431013MillenniumAvalign Technologies, Inc.GEN2026-09-18
00190776429034MillenniumAvalign Technologies, Inc.GEN2026-09-04
00190776429058MillenniumAvalign Technologies, Inc.GEN2026-09-04
04058749001280NAFehling Instruments GmbH & Co. KGGEN2026-09-04
00190776427993MillenniumAvalign Technologies, Inc.GEN2026-08-27
00190776428167MillenniumAvalign Technologies, Inc.GEN2026-08-27
00190776427559MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427665MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427740MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427764MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427771MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427788MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776427795MillenniumAvalign Technologies, Inc.GEN2026-08-26
00190776420369MillenniumAvalign Technologies, Inc.GEN2026-08-25
00190776418236MillenniumAvalign Technologies, Inc.GEN2026-08-23
00190776427238MillenniumAvalign Technologies, Inc.GEN2026-08-21
00190776427269MillenniumAvalign Technologies, Inc.GEN2026-08-21