FDA.reportPublic FDA data

Prestige LP Streamlined Instruments

Primary DI
00643169752986
Brand
Prestige LP Streamlined Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
6975208
Device description
GUIDE 6975208 DRILL GUIDE 8MM
Published
2018-02-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MJOProsthesis, intervertebral disc

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJOProsthesis, Intervertebral DiscUnknown3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P090029007

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P090029007PRESTIGE LP CERVICAL DISCMedtronic Sofamor Danek USA, Inc.2014-07-24MJO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169752986PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169752986006431697529866431697529860643169752986

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Width8Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150041183N/A593250152026-07-17
00199150072323Medtronic Reusable InstrumentsX66309032026-07-19
00199150074525Medtronic Reusable InstrumentsEX01260082026-07-19
00199150076024Medtronic Reusable InstrumentsEX03260062026-07-17
00199150081875Medtronic Reusable InstrumentsX04260032026-07-19
00643169511651SOVEREIGN™ Spinal System90100020222026-07-19
00643169511675MSB SOVEREIGN™ Spinal System90100020232026-07-19
00643169511682MSB SOVEREIGN™ Spinal System90100020242026-07-19
00643169511705MSB SOVEREIGN™ Spinal System90100020302026-07-17
00643169511712MSB SOVEREIGN™ Spinal System90100020312026-07-19
00643169511729MSB SOVEREIGN™ Spinal System90100020322026-07-19
00643169511736MSB SOVEREIGN™ Spinal System90100020332026-07-19
00643169511774MSB SOVEREIGN™ Spinal System90100020342026-07-19
00643169511781MSB SOVEREIGN™ Spinal System90100020352026-07-19
00643169511798MSB SOVEREIGN™ Spinal System90100020362026-07-19
00643169511804MSB SOVEREIGN™ Spinal System90100020372026-07-19
00643169511811MSB SOVEREIGN™ Spinal System90100020382026-07-19
00643169511828MSB SOVEREIGN™ Spinal System90100020392026-07-19
00643169511873MSB SOVEREIGN™ Spinal System90100020052026-07-19
00643169511880MSB SOVEREIGN™ Spinal System90100020062026-07-19

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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M670107732500Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
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M670107733560Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107733600Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
M670107733660Synergy DiscSynergy Spine Solutions IncMJO2026-03-18
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