FDA.report

Belvedere™

Primary DI
00841508107262
Brand
Belvedere™
Company
NEUROSTRUCTURES, INC
Model
12-09-030
Device description
6.5mm Cortical Bone Screw 30mm
Published
2016-11-22
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
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications

CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00841508107262PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00841508107262008415081072628415081072620841508107262

GMDN Terms

TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
8003526103customerservice@neurostructures.com

Regulatory Flags

DUNS number
079391677
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
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

Other Devices From This Company

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00841508104216Cavetto100018-1214102016-01-08
00841508104223Cavetto100018-121442016-01-08
00841508104230Cavetto100018-121452016-01-11
00841508104247Cavetto100018-121462016-01-11
00841508104254Cavetto100018-121472016-01-11
00841508104261Cavetto100018-121482016-01-11
00841508104278Cavetto100018-121492016-01-11
00841508104285Cavetto100018-1416102016-01-11
00841508104292Cavetto100018-141642016-01-11
00841508104308Cavetto100018-141652016-01-11
00841508104315Cavetto100018-141662016-01-11
00841508104322Cavetto100018-141672016-01-11
00841508104339Cavetto100018-141682016-01-11
00841508104346Cavetto100018-141692016-01-11
00841508104353Cavetto100018-161842016-01-11
00841508104360Cavetto100018-161852016-01-11
00841508104377Cavetto100018-161862016-01-11
00841508104384Cavetto100018-161872016-01-11
00841508104391Cavetto100018-161882016-01-11
00841508104407Cavetto100018-161892016-01-11

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