FDA.report

Clutch

Primary DI
08406061017391
Brand
Clutch
Company
SPINAL ELEMENTS, INC.
Model
86002-013
Device description
13 X 39MM FLARED Z PLATE PC
Published
2018-12-26
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

Related Records

Contact Domains

Product Codes

CodeName
PEKSpinous process plate

Product Code Classifications

CodeDeviceSpecialtyClass
PEKSpinous Process PlateOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
08406061017391PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
08406061017391084060610173918406061017391

GMDN Terms

TermDefinition
Interspinous spinal fixation implantAn implantable device intended to be attached to two adjacent vertebral spinous processes to provide immobilization and stabilization of spinal segments as an adjunct to bony fusion in the treatment of spinal conditions (e.g., degenerative disc disease, spondylolisthesis, tumour, trauma). It is intended to be used on the thoracic, lumbar or sacral spine during a minimally-invasive procedure. It is made of metal [e.g., titanium (Ti), nickel-titanium alloy (Nitinol)] and may incorporate bone graft pockets. This is a single-use device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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
true
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

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