FDA.reportPublic FDA data

Solum IV Bone Void Filler

Primary DI
00817771028740
Brand
Solum IV Bone Void Filler
Company
Celling Biosciences
Model
Solum IV - 5cc
Catalog number
1201-0050
Published
2016-09-20
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
K132470000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132470000SOLUM IV BONE VOID FILLERSpinesmith Partners, Llp2014-05-21MQV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817771028740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817771028740008177710287408177710287400817771028740

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
021560394
Device count
1
Lot or batch
true
Expiration date on label
true
Donation ID number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817771027316SpineSmith Fusionary Graft Delivery System0851-00300851-00302016-12-29
00817771027323SpineSmith Fusionary Graft Delivery System0851-00610851-00612016-12-29
00817771027354SpineSmith Fusionary Graft Delivery System0851-10600851-10602016-12-28
00817771027361SpineSmith Fusionary Graft Delivery System0851-10700851-10702016-12-28
00817771027378SpineSmith Fusionary Graft Delivery System0851-30600851-30602016-12-29
00817771027385SpineSmith Fusionary Graft Delivery System0852-00010852-00012016-12-29
00817771027392SpineSmith Fusionary Graft Delivery System0852-01200852-01202016-12-29
00817771029761Solum FlowSolum Flow - 10cc1206-01002025-08-05
00817771027637SpineSmith IN:C2 Spinal Fixation System1100-0002-PL1100-0002-PL2018-02-14
00817771029815SpineSmith IN:C2 Spinal Fixation System1110-0001-PL1110-0001-PL2018-02-14
00817771029822SpineSmith IN:C2 Spinal Fixation System1110-0002-PL1110-0002-PL2018-02-14
00817771027439ART BMC System Centrifuge0882-00010882-00012025-04-11
00817771027460ART BMC System Centrifuge0882-00040882-00042025-04-11
00817771027484ART BMC System Centrifuge0882-00200882-00202025-04-11
00817771028788Celling ART BMC Plus 0866-00020866-00022025-04-11
00817771028795Celling ART BMC 0886-00010886-00012025-04-11
00817771028825Celling ART PRP 2-Step 60 Kit1651-00041651-00042025-04-11
00817771028849Celling Cardio Application Kit0851-00030851-00032025-04-11
00817771028856Celling ART PRP 2-Step 120 Kit1651-00051651-00052025-04-11
00817771028870Celling ART PRP 2-Step Mini Kit1651-00021651-00022025-04-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
07610221017867Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017874Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017881Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017898Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017904Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017911Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
07610221017928Device 300423 GranulesGeistlich Pharma AGMQV2026-06-01
03760191133723GlassBone GranulesNORAKERMQV2026-05-27
03760191133730GlassBone GranulesNORAKERMQV2026-05-27
03760191133747GlassBone GranulesNORAKERMQV2026-05-27
03760191133754GlassBone GranulesNORAKERMQV2026-05-27
03760191133761GlassBone GranulesNORAKERMQV2026-05-27
03760191133778GlassBone GranulesNORAKERMQV2026-05-27
03760191133785GlassBone GranulesNORAKERMQV2026-05-27
03760191134812AktiBone GranulesNORAKERMQV2026-05-27
03760191134829AktiBone GranulesNORAKERMQV2026-05-27
03760191134836AktiBone GranulesNORAKERMQV2026-05-27
03760191134843AktiBone GranulesNORAKERMQV2026-05-27
03760191134850AktiBone GranulesNORAKERMQV2026-05-27
03760191134867AktiBone GranulesNORAKERMQV2026-05-27
03760191134874AktiBone GranulesNORAKERMQV2026-05-27
03760191134881MectaBlast GranulesNORAKERMQV2026-05-27
03760191134898MectaBlast GranulesNORAKERMQV2026-05-27
03760191134904MectaBlast GranulesNORAKERMQV2026-05-27
03760191134911MectaBlast GranulesNORAKERMQV2026-05-27
03760191134928MectaBlast GranulesNORAKERMQV2026-05-27