FDA.reportPublic FDA data

Crystal

Primary DI
00840606111812
Brand
Crystal
Company
SPINAL ELEMENTS, INC.
Model
21411-709
Device description
14MM X 11MM X 9MM CAGE 7°
Published
2015-07-29
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ODPIntervertebral fusion device with bone graft, cervical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ODPIntervertebral Fusion Device With Bone Graft, CervicalOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840606111812PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840606111812008406061118128406061118120840606111812

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(760)607-0121info@spinalelements.com

Regulatory Flags#

DUNS number
610712213
Device count
1
DM exempt
true
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840606174800Primus66440-0002026-03-06
00840606187138Primus66900-0002026-02-27
00840606187145Primus66900-000-012026-02-27
00840606187152Primus66900-000-022026-02-27
00840606187169Primus66900-000-032026-02-27
00840606187176Primus66900-000-042026-02-27
00840606187268Primus66900-0302026-02-27
00840606187275Primus66900-030-012026-02-27
00840606187282Primus66900-030-022026-02-27
00840606187299Primus66900-030-032026-02-27
00840606187305Primus66900-030-042026-02-27
00840606187312Primus66900-030-052026-02-27
00840606187329Primus66900-030-062026-02-27
00840606187336Primus66900-030-072026-02-27
00840606187343Primus66900-030-082026-02-27
00840606187367Primus66900-030-092026-02-27
00840606185172Primus66430-0182026-01-23
00840606185189Primus66430-0242026-01-23
00840606185196Primus66430-1182026-01-23
00840606185202Primus66430-1242026-01-23

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840283404245ClariVy™VY SPINE LLCODP2026-03-19
00840283404252ClariVy™VY SPINE LLCODP2026-03-19
00840283404269ClariVy™VY SPINE LLCODP2026-03-19
00840283404276ClariVy™VY SPINE LLCODP2026-03-19
00840283404283ClariVy™VY SPINE LLCODP2026-03-19
00840493416687LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
00840493416694LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
00840493416700LUX Expandable Interbody SystemXENIX MEDICAL LLCODP2026-03-13
00841193127521EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127538EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127545EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127552EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127569EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127576EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127583EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127590EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127606EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127613EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127620EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127637EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127644EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127651EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127668EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
00841193127675EVOL®ha-Hyper C Cervical Interbody SystemCutting Edge Spine, LLCODP2026-03-11
10195860030421E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030438E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030445E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030452E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030506E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20
10195860030537E3D-C Interbody SystemEvolution Spine LLCODP2026-02-20