FDA.reportPublic FDA data

ShurFit Lumbar Interbody

Primary DI
00840019951302
Brand
ShurFit Lumbar Interbody
Company
PRECISION SPINE, INC.
Model
72-OPC-2414
Catalog number
72-OPC-2414
Device description
24 x 14mm 12° Oblique PEEK Interbody
Published
2023-03-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K212075000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212075000ShurFit Lumbar Interbody SystemPrecision Spine, Inc.2021-12-08MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019951302PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019951302008400199513028400199513020840019951302

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.

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
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840019934848Reform Ti39-TD-552539-TD-55252019-10-04
00840019934855Reform Ti39-TD-553039-TD-55302019-10-04
00840019934862Reform Ti39-TD-553539-TD-55352019-10-04
00840019934879Reform Ti39-TD-554039-TD-55402019-10-04
00840019934886Reform Ti39-TD-554539-TD-55452019-10-04
00840019934893Reform Ti39-TD-555039-TD-55502019-10-04
00840019935074Reform Ti39-TD-757039-TD-75702019-10-04
00840019935081Reform Ti39-TD-758039-TD-75802019-10-04
00840019935098Reform Ti39-TD-853539-TD-85352019-10-04
00840019935104Reform Ti39-TD-854039-TD-85402019-10-04
00840019935111Reform Ti39-TD-854539-TD-85452019-10-04
00840019935128Reform Ti39-TD-855039-TD-85502019-10-07
00840019935159Reform Ti39-TD-857039-TD-85702019-10-07
00840019935166Reform Ti39-TD-858039-TD-85802019-10-07
00840019935173Reform Ti39-TD-859039-TD-85902019-10-07
00840019935180Reform Ti39-TD-850039-TD-85002019-10-07
00840019935197Reform Ti39-TD-851139-TD-85112019-10-07
00840019935203Reform Ti39-TD-851239-TD-85122019-10-07
00840019935210Reform Ti39-TD-954039-TD-95402019-10-07
00840019935227Reform Ti39-TD-954539-TD-95452019-10-07

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