FDA.reportPublic FDA data

Silverstone Interbody Fusion System

Primary DI
B417PS3010111
Brand
Silverstone Interbody Fusion System
Company
Altus Spine, LLC
Model
PS-301011
Device description
PEEK, TLIF, 30L X 10W X 11H
Published
2016-10-28
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
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
B417PS3010111PrimaryHIBCC0
00843210118178SecondaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00843210118178008432101181788432101181780843210118178

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle7degree

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(610)355-4156Info@altus-spine.com

Regulatory Flags#

DUNS number
078331322
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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 DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843210189505Brickyard Stand-Alone ALIF1030-0101G-452025-09-02
00843210190457Brickyard Stand-Alone ALIF1030-3215G-452025-09-02
00843210190464Brickyard Stand-Alone ALIF1030-3220G-452025-09-02
00843210190471Brickyard Stand-Alone ALIF1030-3225G-452025-09-02
00843210190488Brickyard Stand-Alone ALIF1030-3230G-452025-09-02
00843210190495Brickyard Stand-Alone ALIF1030-3235G-452025-09-02
00843210190501Brickyard Stand-Alone ALIF1030-3240G-452025-09-02
00843210176567Sochi300-09012025-03-13
00843210170749Indy Standalone1030-0301G-452024-10-07
00843210189154Brickyard Stand-Alone ALIF1020-20002024-10-07
00843210189437Brickyard Stand-Alone ALIF1030-0301G-452024-10-07
00843210159492Indy StandaloneSL382716122024-10-04
00843210161358Indy StandaloneSL38271612T2024-10-04
00843210169118Indy Standalone1030-42152024-10-04
00843210169125Indy Standalone1030-42202024-10-04
00843210169132Indy Standalone1030-42252024-10-04
00843210169149Indy Standalone1030-42302024-10-04
00843210169156Indy Standalone1030-42352024-10-04
00843210169163Indy Standalone1030-42402024-10-04
00843210169170Indy Standalone1030-02152024-10-04

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