FDA.reportPublic FDA data

HARPOON LUMBAR SPACER SYSTEM

Primary DI
00840996181853
Brand
HARPOON LUMBAR SPACER SYSTEM
Company
Choice Spine, LP
Model
PP40-36094
Device description
PLI,SPACER,HARPOON,36X9, 4 DEG
Published
2023-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K140142000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K140142000CHOICE SPINE LUMBAR SPACER SYSTEM (SABRE, SHARK, HORNET, HARPOON)Choicespine, LP2014-07-16MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840996181853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840996181853008409961818538409961818530840996181853

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

Contacts#

Phone, Email table
PhoneEmail
+1(865)246-3333info@choicespine.net

Regulatory Flags#

DUNS number
078293017
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840996183154Ambassador05-109-18-00272023-02-03
00810211101256THUNDERBOLTM070-02312026-02-13
00840996176552BOOMERANGBT20-D45132026-01-15
00840996176569BOOMERANGBT20-D45152026-01-15
00840996176576BoomerangBT20-D45172026-01-15
00840996176583BOOMERANGB070-00002026-01-15
00840996176590BOOMERANGB070-D0102026-01-15
00840996176606BoomerangB070-00012026-01-15
00840996176392VEo LateralV070-00902022-11-16
00840996176408VEo LateralV070-00912022-11-16
00840996176415VEo LateralV070-00922022-11-16
00840996176422VEo LateralV070-00932022-11-16
00840996176125TiGER SHARK Interbody Fusion SystemS-PT36-240962019-01-05
00840996176132TiGER SHARK Interbody Fusion SystemS-PT36-241062019-01-05
00840996176149TiGER SHARK Interbody Fusion SystemS-PT36-241162019-01-05
00840996176156TiGER SHARK Interbody Fusion SystemS-PT36-241262019-01-05
00840996176163TiGER SHARK Interbody Fusion SystemS-PT36-241362019-01-05
00840996176170TiGER SHARK Interbody Fusion SystemS-PT36-241462019-01-05
00840996176187TiGER SHARK Interbody Fusion SystemS-PT36-241562019-01-05
00840996176194TiGER SHARK Interbody Fusion SystemS-PT36-241662019-01-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888857461819CASCADIA™ Interbody SystemVB Spine LLCMQP2019-10-31
10888857461888CASCADIA™ Interbody SystemVB Spine LLCMQP2019-10-31
10888857218772CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857218963CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857219076CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857219489CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
10888857219595CASCADIA™ Interbody SystemVB Spine LLCMQP2015-12-16
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