FDA.reportPublic FDA data

PEEK SPACER WITH X-RAY MARKERS

Primary DI
00888480469179
Brand
PEEK SPACER WITH X-RAY MARKERS
Company
BIOMET SPINE LLC
Model
14-531158
Catalog number
14-531158
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MQPSPINAL VERTEBRAL BODY REPLACEMENT DEVICE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQPSpinal Vertebral Body Replacement DeviceOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00888480469179PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00888480469179008884804691798884804691790888480469179

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal fusion cage, sterileA sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)447-3625USBROCustomerService@zimmerbiomet.com

Regulatory Flags#

DUNS number
018577570
Device count
1
Lot or batch
true
Expiration date on label
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
04052536212989ADDplusUlrich GmbH & Co. KGMQP2026-03-03
04052536212996ADDplusUlrich GmbH & Co. KGMQP2026-03-03
04052536213009ADDplusUlrich GmbH & Co. KGMQP2026-03-03
04052536213016ADDplusUlrich GmbH & Co. KGMQP2026-03-03
04052536213023ADDplusUlrich GmbH & Co. KGMQP2026-03-03
04052536212804Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212811Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212828Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212835Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212842Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212859Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212866Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212873Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212880Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212897Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212903Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212910Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212927Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212934Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212941Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212958Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212965Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
04052536212972Small VBR (ADD)Ulrich GmbH & Co. KGMQP2026-03-02
00763000857936T2 STRATOSPHERE™ Expandable Corpectomy SystemMEDTRONIC SOFAMOR DANEK, INC.MQP2026-02-27
00810141048478Foundation Surgical VertiwedgeFOUNDATION SURGICAL GROUP INCMQP2026-02-26
00810141048485Foundation Surgical VertiwedgeFOUNDATION SURGICAL GROUP INCMQP2026-02-26
00810141048492Foundation Surgical VertiwedgeFOUNDATION SURGICAL GROUP INCMQP2026-02-26
00810141048508Foundation Surgical VertiwedgeFOUNDATION SURGICAL GROUP INCMQP2026-02-26
00810141048515Foundation Surgical VertiwedgeFOUNDATION SURGICAL GROUP INCMQP2026-02-26
00810141048577Foundation Surgical VertiwedgeFOUNDATION SURGICAL GROUP INCMQP2026-02-26