FDA.reportPublic FDA data

Sypher ALIF Spacer System

Primary DI
00812593020538
Brand
Sypher ALIF Spacer System
Company
Biogennix, LLC
Model
SAS-5535
Catalog number
SAS-5535
Device description
Sypher Bone Screw - 5.5mm Diameter X 35mm Length
Published
2016-12-19
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

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141798000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141798000SYPHER SPACER SYSTEMBiogennix, LLC2015-02-19OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812593020538PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812593020538008125930205388125930205380812593020538

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, sterile, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold plates, or other stabilization device, to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length35Millimeter
Outer Diameter5.5Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832270370
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812593023188osteoSPAN Granules120-10G2026-07-24
00812593023195SUMMIT Matrix Granules 10cc9241102026-07-24
00812593023201SUMMIT Matrix Granules 30cc9241302026-07-24
00812593023119NeoForm AWCNFAWC-0252026-04-27
00812593023126NeoForm AWCNFAWC-0502026-04-27
00812593023072NeoSurg Surgical CollagenNSC-3122026-04-22
00812593023089ossFX Surgical CollagenAXB-OSF-2502026-04-22
00812593023096ossFX Surgical CollagenAXB-OSF-5002026-04-22
00812593023102ColSyntekZS3001-52026-04-22
00812593023058Agilon Surgical Collagen +ASC-0152026-04-02
00812593023065Agilon Surgical Collagen +ASC-0302026-04-02
00812593023034CuraSurg Surgical CollagenCSC-0252026-04-01
00812593023041CuraSurg Surgical CollagenCSC-0502026-04-01
00812593023010Agilon Surgical Collagen+ASC-0252026-03-24
00812593023027Agilon Surgical Collagen+ASC-0502026-03-24
00812593021931Summit Moldable9242012025-02-21
00812593021948Summit Moldable9242022025-02-21
00812593021955Summit Moldable9242052025-02-21
00812593021962Summit Moldable9242102025-02-21
00812593021979Summit Strip9243052025-02-21

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