FDA.reportPublic FDA data

Osteoamp Flowable Access Cannula

Primary DI
00816986020525
Brand
Osteoamp Flowable Access Cannula
Company
BIOVENTUS LLC
Model
OFAC-C
Catalog number
OFAC-C
Device description
The Allograft Delivery Device consists of a cannula and push rod made of biocompatible polypropylene. The device is provided sterile and is intended to be used with hydrated allograft to facilitate delivery into bony defects in orthopedic surgical sites.
Published
2024-11-21
Public version status
New
Distribution status
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
FMFSyringe, Piston

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FMFSyringe, PistonGeneral Hospital2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K233368000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K233368000Allograft Delivery Device (OFAC-C)Bioventus, LLC2024-06-25FMF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00816986020525PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00816986020525008169860205258169860205250816986020525

GMDN Terms#

Term, Definition table
TermDefinition
Bone grafting cannulaA rigid tube intended to be used surgically to introduce a bone void filler (e.g., a bone matrix implant/bone substitute) in voids or gaps of the skeletal system (i.e., extremities, craniofacial bone, spine, and pelvis) to fill defects in the bone structure created surgically or traumatically. It is typically made of metal materials (e.g., high-grade stainless steel) with or without a plastic hub at the distal end to connect to a syringe or other device that propels the filler. The device may also be used for the delivery of orthopaedic cement. This is a single-use device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature11 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
800-637-4391CSSurgical@bioventusglobal.com

Regulatory Flags#

DUNS number
078450878
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816986020099OSTEOFUSE7.5gOF0022019-02-22
00816986020105OSTEOFUSE15gOF0032019-02-22
00816986020136UNITE Bioactive Bone Graft3.75gMSBG03752019-02-22
00816986020143UNITE Bioactive Bone Graft7.5gMSBG07502019-02-22
00816986020150UNITE Bioactive Bone Graft15gMSBG15002019-02-22
00816986020006SIGNAFUSE15gSGF-1502019-02-22
00816986020013SIGNAFUSE7.5gSGF-0752019-02-22
00816986020020SIGNAFUSE3.75gSGF-0372019-02-22
00816986020082OSTEOFUSE3.75gOF0012019-02-22
M937710346601EXOGEN Metatarsal Strap710346602021-12-17
M937710344001EXOGEN® Ultrasound Bone Healing System71034400710344002017-01-12
M937710346001EXOGEN® Ultrasound Bone Healing System71034600710346002017-01-12
00816986020549TalisMann Implant KitTM-10002025-09-01
00816986020556StimTrial Surgical KitTS-10002025-09-01
00816986020570StimTrial Patient KitTS-60002025-09-01
00816986020587StimTrial Stimulator KitTS-50002025-09-01
00816986020617Bioventus User KitPNS-50002025-09-01
00816986020624Bioventus Clinician KitPNS-10002025-09-01
10389130444418SUPARTZ FX sodium hyaluronate715644442023-09-28
00816986020037INTERFACEIFBG100IFBG1002019-05-06

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Primary DI, Brand, Company table
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