FDA.reportPublic FDA data

PLEXUR P®

Primary DI
00613994986580
Brand
PLEXUR P®
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
6000-320
Device description
BLOCK 6000-320 PLEXUR P 20MMX20MMX20MM
Published
2015-07-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
K061982000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K061982000PLEXUR POsteotech, Inc.2007-02-07MBP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994986580PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994986580006139949865806139949865800613994986580

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
Height20Millimeter
Length20Millimeter
Width20Millimeter

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
Lot or batch
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00643169190382CLYDESDALE PTC™ Spinal System49268552016-04-17
00643169190399CLYDESDALE PTC™ Spinal System49268502016-04-17
00643169190405CLYDESDALE PTC™ Spinal System49268452016-04-18
00643169190412CLYDESDALE PTC™ Spinal System49268402016-04-17
00643169190429CLYDESDALE PTC™ Spinal System49266602016-04-17
00643169190436CLYDESDALE PTC™ Spinal System49266552016-04-17
00643169190443CLYDESDALE PTC™ Spinal System49266502016-04-17
00643169190450CLYDESDALE PTC™ Spinal System49266452016-04-18
00643169190467CLYDESDALE PTC™ Spinal System49266402016-04-18
00643169190481CLYDESDALE PTC™ Spinal System49264552016-04-18
00643169190504CLYDESDALE PTC™ Spinal System49868602016-04-17
00643169190559CLYDESDALE PTC™ Spinal System49866602016-04-17
00643169190566CLYDESDALE PTC™ Spinal System49866552016-04-17
00643169190573CLYDESDALE PTC™ Spinal System49866502016-04-17
00643169190580CLYDESDALE PTC™ Spinal System49866452016-04-17
00643169190597CLYDESDALE PTC™ Spinal System49866402016-04-17
00643169190603CLYDESDALE PTC™ Spinal System49864602016-04-17
00643169190610CLYDESDALE PTC™ Spinal System49864552016-04-18
00643169190634CLYDESDALE PTC™ Spinal System49864452016-04-17
00643169190658CLYDESDALE PTC™ Spinal System49862602016-04-18

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Primary DI, Brand, Company table
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00849777014076Union DBM, 5ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014076Union DBM, 5ccXtant Medical Holdings, Inc.MBP2026-06-24
00849777014083Union DBM, 10ccXtant Medical Holdings, Inc.MQV2026-06-24
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