FDA.report

Blustone Synergy Cervical Rasp

Primary DI
00810482030873
Brand
Blustone Synergy Cervical Rasp
Company
BLUSTONE SYNERGY, LLC
Model
9014-CRL8
Device description
The Blustone Synergy Cervical Interbody Fusion System is implanted using a combination of device specific and universal class I instruments manufactured from stainless steel materials that conform to ASTM F899. The cervical rasps are available in parallel and lordotic configurations, 14mmX11mm and 17mmX13mm sizes and thicknesses between 5mm and 11mm.
Published
2018-01-29
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
false

Related Records

Contact Domains

Product Codes

CodeName
HTRRasp

Product Code Classifications

CodeDeviceSpecialtyClass
HTRRaspGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810482030873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810482030873008104820308738104820308730810482030873

GMDN Terms

TermDefinition
Bone fileA hand-held, manually-operated, instrument that has various forms of fine ridged cutting surfaces along part of or all of its working end that is used for cutting and smoothing (filing) bone tissue. It is made of high-grade steel and may be a one-piece instrument with a handle at the proximal end. The distal end may be flat or profiled (e.g., flat on one side and convex on the other). This device is typically used in orthopaedics, plastic surgery and dentistry. This is a reusable device.

Device Sizes

TypeValueUnit
Length14Millimeter

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
800-232-9108admin@blustonesynergy.com

Regulatory Flags

DUNS number
033467608
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

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810482030019Blustone Synergy Cervical Interbody Fusion System (Slate)1411-CL052018-01-29
00810482030026Blustone Synergy Cervical Interbody Fusion System (Slate)1411-CL062018-01-29
00810482030033Blustone Synergy Cervical Interbody Fusion System (Slate)1411-CL072018-01-29
00810482030040Blustone Synergy Cervical Interbody Fusion System (Slate)1411-CL082018-01-29
00810482030057Blustone Synergy Cervical Interbody Fusion System (Slate)1411-CL092018-01-29
00810482030064Blustone Synergy Cervical Interbody Fusion System (Slate)1411-CL102018-01-29
00810482030071Blustone Synergy Cervical Interbody Fusion System (Slate)1411-CL112018-01-29
00810482030088Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C0202018-01-29
00810482030095Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C0232018-01-29
00810482030101Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C0262018-01-29
00810482030118Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C0292018-01-29
00810482030125Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C0322018-01-29
00810482030132Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C0352018-01-29
00810482030149Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C0382018-01-29
00810482030156Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C0412018-01-29
00810482030163Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C0442018-01-29
00810482030170Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C0472018-01-29
00810482030187Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C0502018-01-29
00810482030194Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C3202018-01-29
00810482030200Blustone Synergy Spinal Intervertebral Body Fixation System (Silica)1513-C3232018-01-29

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