FDA.reportPublic FDA data

ShurFit 2C Lumbar Interbody

Primary DI
00840019930420
Brand
ShurFit 2C Lumbar Interbody
Company
PRECISION SPINE, INC.
Model
23-PC1855-08-2C
Catalog number
23-PC1855-08-2C
Device description
18x55x08mm - 0° PEEK 2C Cage
Published
2019-03-28
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
K171657000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171657000ShurFit 2C Lumbar Interbody Fusion SystemPrecision Spine, Inc.2017-08-11MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019930420PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019930420008400199304208400199304200840019930420

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840019978156Reform Ti39-TM-454539-TM-45452026-10-19
00840019978163Reform Ti39-TM-552039-TM-55202026-10-19
00840019978170Reform Ti39-TM-552539-TM-55252026-10-19
00840019978187Reform Ti39-TM-553039-TM-55302026-10-19
00840019978194Reform Ti39-TM-553539-TM-55352026-10-19
00840019978200Reform Ti39-TM-554039-TM-55402026-10-19
00840019978217Reform Ti39-TM-554539-TM-55452026-10-19
00840019978224Reform Ti39-TM-555039-TM-55502026-10-19
00840019978231Reform Ti39-TM-555539-TM-55552026-10-19
00840019978248Reform Ti39-TM-556039-TM-55602026-10-19
00840019978255Reform Ti39-TM-652539-TM-65252026-10-19
00840019978262Reform Ti39-TM-653039-TM-65302026-10-19
00840019978279Reform Ti39-TM-653539-TM-65352026-10-19
00840019978286Reform Ti39-TM-654039-TM-65402026-10-19
00840019978293Reform Ti39-TM-654539-TM-65452026-10-19
00840019978309Reform Ti39-TM-655039-TM-65502026-10-19
00840019978316Reform Ti39-TM-655539-TM-65552026-10-19
00840019978323Reform Ti39-TM-656039-TM-65602026-10-19
00840019978330Reform Ti39-TM-753039-TM-75302026-10-19
00840019978347Reform Ti39-TM-753539-TM-75352026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606176347LucentSPINAL ELEMENTS, INC.MAX2026-10-22
00840606184847LucentSPINAL ELEMENTS, INC.MAX2026-10-22
00840606197106LucentSPINAL ELEMENTS, INC.MAX2026-10-22
B648C29510000Savant Lumbar Interbody Fusion SystemCURITEVA, INC.MAX2026-10-19
M719GLL11403DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
M719GLL11503DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
M719GLL11603DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
00810161900381EARP, 14X25X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900398EARP, 14X25X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900404EARP, 14X25X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900411EARP, 14X25X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900428EARP, 14X30X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900435EARP, 14X30X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900442EARP, 14X30X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900459EARP, 14X30X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900466EARP, 14X35X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900473EARP, 14X35X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900480EARP, 14X35X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900497EARP, 14X35X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900503EARP, 14X40X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900510EARP, 14X40X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900527EARP, 14X40X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900534EARP, 18X30X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900541EARP, 18X30X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900558EARP, 18X30X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900565EARP, 18X30X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900572EARP, 18X35X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900589EARP, 18X35X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900596EARP, 18X35X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900602EARP, 18X35X14 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16