FDA.reportPublic FDA data

Summit Strip

Primary DI
00812593021979
Brand
Summit Strip
Company
Biogennix, LLC
Model
924305
Device description
Summit Matrix Strip Medium
Published
2025-02-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193487000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193487000Agilon StripBiogennix, LLC2020-03-30MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812593021979PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812593021979008125930219798125930219790812593021979

GMDN Terms#

Term, Definition table
TermDefinition
Synthetic bone graftAn artificial bone substitute used for structural bone replacement typically when bone is lost due to disease (e.g., osteoporosis) or injury. It consists mainly of porous and mesh ceramic materials that provide a framework for bone growth, or harvested sea coral that serves as an additive, extender, or provides a framework for bone growth. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
832270370
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812593023119NeoForm AWCNFAWC-0252026-04-27
00812593023126NeoForm AWCNFAWC-0502026-04-27
00812593023072NeoSurg Surgical CollagenNSC-3122026-04-22
00812593023089ossFX Surgical CollagenAXB-OSF-2502026-04-22
00812593023096ossFX Surgical CollagenAXB-OSF-5002026-04-22
00812593023102ColSyntekZS3001-52026-04-22
00812593023058Agilon Surgical Collagen +ASC-0152026-04-02
00812593023065Agilon Surgical Collagen +ASC-0302026-04-02
00812593023034CuraSurg Surgical CollagenCSC-0252026-04-01
00812593023041CuraSurg Surgical CollagenCSC-0502026-04-01
00812593023010Agilon Surgical Collagen+ASC-0252026-03-24
00812593023027Agilon Surgical Collagen+ASC-0502026-03-24
00812593021931Summit Moldable9242012025-02-21
00812593021948Summit Moldable9242022025-02-21
00812593021955Summit Moldable9242052025-02-21
00812593021962Summit Moldable9242102025-02-21
00812593021986Summit Strip9243102025-02-21
00812593022952NeoForm Matrix005N-NFS2025-09-22
00812593022969NeoForm MatrixNFS2025-09-22
00812593022976NeoForm Matrix010F-NFS2025-09-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00816125027125VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
00816125027132VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
00816125027149VitaFuse™ Bioactive Glass GraftBERKELEY ADVANCED BIOMATERIALS, LLCMQV2026-07-06
ECUR9920302VerteFramecurasan AGMQV2026-06-25
ECUR9920305VerteFramecurasan AGMQV2026-06-25
ECUR9920310VerteFramecurasan AGMQV2026-06-25
ECURCCLF25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF25250CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLF2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM25100CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2512CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2525CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURCCLM2550CERACELL Ortho Foamcurasan AGMQV2026-06-25
ECURTFF1050TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFF1100TriForm Flexible Foam Stripcurasan AGMQV2026-06-25
ECURTFM1050TriForm Moldable Foamcurasan AGMQV2026-06-25
ECURTFM1100TriForm Moldable Foamcurasan AGMQV2026-06-25
00849777014052Union DBM, 1ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014069Union DBM, 2.5ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014076Union DBM, 5ccXtant Medical Holdings, Inc.MQV2026-06-24
00849777014083Union DBM, 10ccXtant Medical Holdings, Inc.MQV2026-06-24
06429810349293Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349316Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349330Adaptos®FuseBiomendex OyMQV2026-06-24
06429810349354Adaptos®FuseBiomendex OyMQV2026-06-24
W4184058150T0474DBX®Musculoskeletal Transplant Foundation, Inc.MQV2026-06-05
07610221017829Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017836Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017843Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017850Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01