FDA.report

Easyspine

Primary DI
03662663003650
Brand
Easyspine
Company
LDR Spine Usa, Inc.
Model
ES176T
Device description
PEDICLE ALPHA SCREW D7 L60mm
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
KWPAppliance, Fixation, Spinal Interlaminal

Product Code Classifications

CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03662663003650PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03662663003650036626630036503662663003650

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. Fixation screws and disposable devices associated with implantation may be included with the device.

Device Sizes

TypeValueUnit
Length60Millimeter
Outer Diameter7Millimeter

Sterilization Methods

Method

Contacts

PhoneEmail
512-344-3333surgeoninfo@ldrspine.com

Regulatory Flags

DUNS number
615789729
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
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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