FDA.report

Omni Stingray

Primary DI
00840916112103
Brand
Omni Stingray
Company
SPINAL ELEMENTS
Model
220LCP
Device description
8mm Stingray II
Published
2017-06-19
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
ODPIntervertebral Fusion Device With Bone Graft, Cervical

Product Code Classifications

CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840916112103PrimaryGS10

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
004022104
Device count
1
DM exempt
false
Premarket exempt
false
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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00840916162054DIAMOND10013-162022-03-03
00840916162061DIAMOND10013-182022-03-03
00840916162078DIAMOND10014-402022-03-03
00840916162085DIAMOND10021-B2022-03-03
00840916162092DIAMOND10025-2-F-B2022-03-03
00840916162108DIAMOND10025-2-V-B2022-03-03
00840916162115DIAMOND100402022-03-03
00840916162122DIAMOND100432022-03-03
00840916162139DIAMOND100472022-03-03
00840916162146DIAMOND100482022-03-03

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