FDA.report

Octane Straight Intervertebral Fusion Device

Primary DI
00840996157377
Brand
Octane Straight Intervertebral Fusion Device
Company
Choice Spine, LP
Model
SK-009584-11
Device description
OCTANE, STD PADDLE SCRAPER, 11MM
Published
2017-06-03
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
false

Related Records

Contact Domains

Product Codes

CodeName
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications

CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840996157377PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00840996157377008409961573778409961573770840996157377

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1(865)246-3333info@choicespine.net

Regulatory Flags

DUNS number
078293017
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

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00840996150705Acapella One05-099-05-14072024-02-24
00840996150712Acapella One05-099-05-14082024-02-24
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00840996150743Acapella One05-099-05-14112024-02-24
00840996150750Acapella One05-099-05-14122024-02-24
00840996150767Acapella One05-099-05-16052024-02-24
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00840996150781Acapella One05-099-05-16072024-02-24
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