FDA.reportPublic FDA data

PLEXUR P®

Primary DI
00643169218185
Brand
PLEXUR P®
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
60000111
Device description
CYLINDER 60000111 PLEXUR P 11MMX25MM
Published
2015-07-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Safe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MBPFiller, bone void, osteoinduction (w/o human growth factor)
MQVFILLER, BONE VOID, CALCIUM COMPOUND

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBPFiller, Bone Void, Osteoinduction (W/O Human Growth Factor)Orthopedic2
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K080511000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K080511000PLEXUR-POsteotech, Inc.2008-04-21MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00643169218185PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169218185006431692181856431692181850643169218185

GMDN Terms#

Term, Definition table
TermDefinition
Cadaveric-donor/synthetic polymer bone graftA sterile implantable device consisting of processed cadaveric human bone (allograft) mixed with bioabsorbable synthetic polymers, intended to fill bony voids or gaps in the skeletal system (e.g., spine, pelvis, extremities) that have been surgically or traumatically created; it may also serve as a bone graft extender. It is designed to be resorbed/remodelled and replaced by host bone during the healing process. It is available as granules or various solid shapes in a variety of sizes.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length11Millimeter
Width25Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
830350380
Device count
1
HCT/P
true
Serial number
true
Donation ID number
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
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