FDA.report

Zavation

Primary DI
00842166187405
Brand
Zavation
Company
ZAVATION LLC
Model
821-102508
Device description
UniFuze-C, Large 8mm without chondroitin sulfate
Published
2023-07-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
MQVFiller, Bone Void, Calcium Compound

Product Code Classifications

CodeDeviceSpecialtyClass
MQVFiller, Bone Void, Calcium CompoundOrthopedic2

Premarket Submissions

SubmissionSupplement
K221726000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K221726000Uni-FuZe-C Bone StripZavation Medical Products, LLC2023-01-18MQV

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842166187405PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00842166187405008421661874058421661874050842166187405

GMDN Terms

TermDefinition
Bone matrix implant, animal-derived, bioabsorbableA sterile bioabsorbable device made primarily of animal-derived bone matrix (e.g., bovine) implanted into the body to provide osteoconductive bone-tissue scaffolds to replace bone lost through trauma, surgery, or pathological conditions (e.g., osteoporosis). It is used to fill bone cavities, defects, and fractures, and contains pores that promote the ingrowth of endogenous bone for skeletal reconstruction or augmentation. It is typically provided as cancellous blocks, chips, or granules of varying sizes, or mouldable materials.

Sterilization Methods

Method
Ethylene Oxide

Contacts

PhoneEmail
601-919-1119info@zavation.com

Regulatory Flags

DUNS number
069472800
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
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
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00197157071400ZAVATION ROD BENDER989-1065-R 2025-09-15
00197157071417ZAVATION ROD BENDER989-1065-L 2025-09-15
00197157071455ZAVATION CADDY1010-9002-12025-09-15
00197157071462ZAVATION CADDY1010-9002-22025-09-15
00197157071479ZAVATION CADDY1010-9002-32025-09-15
00197157071486ZAVATION CADDY1010-9002-42025-09-15
00197157071493ZAVATION CADDY1010-9002-52025-09-15
00197157071509ZAVATION CADDY LID1010-9002-62025-09-15
00197157071516ZAVATION CADDY LID1010-9002-72025-09-15
00197157071523ZAVATION CADDY 1010-9002-82025-09-15
00197157071530ZAVATION CADDY LID1010-9002-92025-09-15
00197157071547ZAVATION CADDY LID1010-9002-102025-09-15
00197157071585ZAVATION RODR5509-0352025-09-15
00197157071592ZAVATION RODR5509-0402025-09-15
00197157071608ZAVATION RODR5509-0452025-09-15
00197157071615ZAVATION RODR5509-0502025-09-15
00197157071622ZAVATION RODR5509-0552025-09-15
00197157071639ZAVATION RODR5509-0602025-09-15
00197157071646ZAVATION RODR5509-0652025-09-15
00197157071653ZAVATION RODR5509-0702025-09-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810131881429OsteoFlo HydroFiber - 1cc LabeledSURGENTEC, LLCMQV2026-03-09
00810131881436OsteoFlo HydroFiber - 3cc LabeledSURGENTEC, LLCMQV2026-03-09
00810131881443OsteoFlo HydroFiber - 6cc LabeledSURGENTEC, LLCMQV2026-03-09
00810131881450OsteoFlo HydroFiber - 12cc LabeledSURGENTEC, LLCMQV2026-03-09
00810131882013Synthetic Fiber Graft - 1ccSURGENTEC, LLCMQV2026-03-09
00810131882020Synthetic Fiber Graft - 3ccSURGENTEC, LLCMQV2026-03-09
00810131882037Synthetic Fiber Graft - 6ccSURGENTEC, LLCMQV2026-03-09
00810131882044Synthetic Fiber Graft - 12ccSURGENTEC, LLCMQV2026-03-09
00810131882136Synthetic Fiber Kit - 1ccSURGENTEC, LLCMQV2026-03-09
00810131882143Synthetic Fiber Kit - 3ccSURGENTEC, LLCMQV2026-03-09
00810131882150Synthetic Fiber Kit - 6ccSURGENTEC, LLCMQV2026-03-09
00810131882167Synthetic Fiber Kit - 12ccSURGENTEC, LLCMQV2026-03-09
00810131883751OsteoFlo Fiber Graft - 1ccSURGENTEC, LLCMQV2026-03-09
00810131883768OsteoFlo Fiber Graft - 3ccSURGENTEC, LLCMQV2026-03-09
00810131883775OsteoFlo Fiber Graft - 6ccSURGENTEC, LLCMQV2026-03-09
00810131883782OsteoFlo Fiber Graft - 12ccSURGENTEC, LLCMQV2026-03-09
00813909013985Putty Syringe with Cannula 2.5ccNOVABONE PRODUCTS, LLCMQV2026-01-28
00813909013992Putty Syringe with Cannula 5.0ccNOVABONE PRODUCTS, LLCMQV2026-01-28
00813909014005Putty Syringe with Cannula 10.0ccNOVABONE PRODUCTS, LLCMQV2026-01-28
00813909013961Putty Syringe 2.5ccNOVABONE PRODUCTS, LLCMQV2026-01-09
00813909013978Putty Syringe 5.0ccNOVABONE PRODUCTS, LLCMQV2026-01-09
00850009685346Backpack AFVentris MedicalMQV2026-01-02
00850009685353Backpack AFVentris MedicalMQV2026-01-02
00813909013909Putty 2.5ccNOVABONE PRODUCTS, LLCMQV2025-12-26
00813909013916Putty 5.0ccNOVABONE PRODUCTS, LLCMQV2025-12-26
00813909013923Porous Morsels 1-2mm 5.0ccNOVABONE PRODUCTS, LLCMQV2025-12-26
00813909013930Porous Morsels 1-2mm 10.0ccNOVABONE PRODUCTS, LLCMQV2025-12-26
00813909013947Putty Syringe 2.5ccNOVABONE PRODUCTS, LLCMQV2025-12-26
00813909013954Putty Syringe 5.0ccNOVABONE PRODUCTS, LLCMQV2025-12-26
05060548020620InteliGraft™BIOSTONE CO. LIMITEDMQV2025-12-10