FDA.reportPublic FDA data

Osteo-P™ Bone Graft Substitute

Primary DI
00811538030106
Brand
Osteo-P™ Bone Graft Substitute
Company
MOLECULAR MATRIX, INC.
Model
BGS-CL15x20
Catalog number
BGS-CL15x20
Device description
Osteo-P™ bone graft substitute cylinder 15 mm diameter x 20 mm length
Published
2018-07-31
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications

CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions

SubmissionSupplement
K170165000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K170165000Osteo-P Bone Graft SubstituteMolecular Matrix, Inc.2017-12-29MQV

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00811538030106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00811538030106008115380301068115380301060811538030106

GMDN Terms

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

Regulatory Flags

DUNS number
064845937
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00811538030113Osteo-P™ Bone Graft Substitute BGS-s25x25x5BGS-s25x25x52023-07-24
00811538030120Osteo-P™ Bone Graft SubstituteBGS-s25x50x5BGS-s25x50x52023-07-24
00811538030137Osteo-P™ Bone Graft SubstituteBGS-s25x75x5BGS-s25x75x52023-07-24
00811538030144Osteo-P™ Bone Graft SubstituteBGS-s25x125x5BGS-s25x125x52023-07-24
00811538030007Osteo-P™ Bone Graft Substitute BGS-G5BGS-G52018-07-31
00811538030014Osteo-P™ Bone Graft SubstituteBGS-G10BGS-G102018-07-31
00811538030021Osteo-P™ Bone Graft SubstituteBGS-G20BGS-G202018-07-31
00811538030038Osteo-P™ Bone Graft Substitute BGS-G30BGS-G302018-07-31
00811538030045Osteo-P™ Bone Graft Substitute BGS-s25x25x3BGS-s25x25x32018-07-31
00811538030052Osteo-P™ Bone Graft SubstituteBGS-s25x50x3BGS-s25x50x32018-07-31
00811538030069Osteo-P™ Bone Graft SubstituteBGS-b10x6x10BGS-b10x6x102018-07-31
00811538030076Osteo-P™ Bone Graft Substitute BGS-b14x10x14BGS-b14x10x142018-07-31
00811538030083Osteo-P™ Bone Graft SubstituteBGS-s25x75x3BGS-s25x75x32018-07-31
00811538030090Osteo-P™ Bone Graft SubstituteBGS-s25x125x3BGS-s25x125x32018-07-31

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