FDA.reportPublic FDA data

PROGENIX® PUTTY and PROGENIX® PLUS

Primary DI
00613994391032
Brand
PROGENIX® PUTTY and PROGENIX® PLUS
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
006005
Device description
DBM 006005 PROGENIX PLUS 5CC
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
NUNBONE GRAFTING MATERIAL, HUMAN SOURCE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUNBone Grafting Material, Human SourceDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K081950000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081950000PROGENIX PLUSMedtronic Sofamor Danek, Inc.2008-07-18NUN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00613994391032PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00613994391032006139943910326139943910320613994391032

GMDN Terms#

Term, Definition table
TermDefinition
Bone matrix implant, human-derivedAn sterile implantable device made primarily of human demineralized bone matrix (DBM) (acid extraction of allogeneic bone resulting in loss of most of the mineralized component but retention of proteins) intended to fill bony voids or gaps caused by trauma or surgery, including use in the maxillofacial and/or mandibular bone. The device is bioabsorbable, osteoconductive, and has demonstrated at least potential osteoinductivity for the stimulation of new bone growth. The DBM may be combined with various carrier compounds (e.g., gelatin, hydrogel, starch) or other materials. It is available in the form of powder, crushed granules, putty, chips, or a gel that can be injected through a syringe.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00store at ambient temperature

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
00199150075034Medtronic Reusable InstrumentsEX02260202026-07-10
00199150081882Medtronic Reusable InstrumentsX04260012026-07-10
00199150081899Medtronic Reusable InstrumentsX04260052026-07-10
00643169839397INFINITY™ Occipitocervical Upper Thoracic System36070052018-06-10
00199150082780Medtronic Reusable InstrumentsX02260232026-07-04
00199150082797Medtronic Reusable InstrumentsX02260242026-07-04
00199150082803Medtronic Reusable InstrumentsX02260252026-07-04
00199150082810Medtronic Reusable InstrumentsX02260262026-07-04
00199150082827Medtronic Reusable InstrumentsX02260272026-07-04
00199150082834Medtronic Reusable InstrumentsX02260282026-07-04
00199150082841Medtronic Reusable InstrumentsX02260292026-07-04
00199150082858Medtronic Reusable InstrumentsX02260302026-07-04
00199150082865Medtronic Reusable InstrumentsX02260312026-07-04
00199150082872Medtronic Reusable InstrumentsX02260322026-07-04
00199150082889Medtronic Reusable InstrumentsX02260332026-07-04
00199150082896Medtronic Reusable InstrumentsX02260342026-07-04
00763000873714MSB SHILLA Growth Guidance System76750252026-07-04
00763000875176MSB SHILLA Growth Guidance System76755352026-07-04
00643169101296MSB VERTEX® Reconstruction SystemG77538052026-06-27
00643169465879MSB CD HORIZON Spinal SystemX10131802026-06-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809963478848SurFuse II PuttyHans Biomed Corp.NUN2026-04-16
08809963478855SurFuse II PuttyHans Biomed Corp.NUN2026-04-16
08809963478862SurFuse II PuttyHans Biomed Corp.NUN2026-04-16
08809963478879ExFuse II PuttyHans Biomed Corp.NUN2026-04-16
08809963478886ExFuse II PuttyHans Biomed Corp.NUN2026-04-16
08809963478893ExFuse II PuttyHans Biomed Corp.NUN2026-04-16
00841336138766Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2025-09-28
00841336138773Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2025-09-28
00841336138797Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2025-09-28
00841336138803Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2025-09-28
00841336114395Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2024-12-11
00841336136229Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2024-12-11
00841336138780Salvin Dental SpecialtiesSALVIN DENTAL SPECIALTIES, LLCNUN2024-12-11
00643169964938GRAFTON™ DBMMEDTRONIC SOFAMOR DANEK, INC.NUN2024-12-05
00841336111905Allo-3D-PlusSALVIN DENTAL SPECIALTIES, LLCNUN2024-07-11
00841336111912Allo-3D-PlusSALVIN DENTAL SPECIALTIES, LLCNUN2024-07-11
00191083045092RegenaVate™ Formable DBM, 1cm x 4cm x 0.5cm, 2ccRti Surgical, Inc.NUN2024-05-27
00191083045108RegenaVate™ Formable DBM RT, 1ccRti Surgical, Inc.NUN2024-05-27
00191083045078RegenaVate™ Formable DBM, 1cm x 1cm x 0.5cm, 0.5ccRti Surgical, Inc.NUN2024-05-27
00191083045085RegenaVate™ Formable DBM, 1cm x 2cm x 0.5cm, 1ccRti Surgical, Inc.NUN2024-05-27
00191083045115RegenaVate™ Formable DBM RT, 2ccRti Surgical, Inc.NUN2024-05-27
00763000140540PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.NUN2021-03-12
00763000140557PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.NUN2021-03-12
00763000140564PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.NUN2021-03-12
00763000140571PROGENIX™ PUTTY and PROGENIX™ PLUSMEDTRONIC SOFAMOR DANEK, INC.NUN2021-03-12
00643169965003GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.NUN2018-08-17
00643169964952GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.NUN2018-07-12
00643169964990GRAFTON® DBMMEDTRONIC SOFAMOR DANEK, INC.NUN2018-06-11
00841336100220ALLO-0.5SALVIN DENTAL SPECIALTIES, LLCNUN2018-02-22
00841336100237ALLO-1.0SALVIN DENTAL SPECIALTIES, LLCNUN2018-02-22