FDA.report

Zavation

Primary DI
00842166184992
Brand
Zavation
Company
ZAVATION LLC
Model
VCF-DSBAK-08
Device description
8 Gauge Direct Unipedicular Bone Access Kit with Drill
Published
2020-07-28
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
NDNCement, Bone, Vertebroplasty

Product Code Classifications

CodeDeviceSpecialtyClass
NDNCement, Bone, VertebroplastyOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00842166184992PrimaryGS10

Alternate GTIN/UPC/EAN values are derived from GS1 digit structure for lookup convenience. Do not treat derived UPC-A or EAN-13 values as separate FDA identifiers. GTIN-14 values with indicator digits 1-9 usually represent packaging levels, cases, pallets, or variable-measure items and are not converted to UPC-A/EAN-13 here.

Alternate GTIN / UPC / EAN Codes

Source identifierSource lengthGTIN-14 normalizedIndicatorUPC-AEAN-13Conversion note
00842166184992140084216618499208421661849920842166184992Indicator 0 and prefix 00 allow UPC-A and EAN-13 conversion.

GMDN Terms

TermDefinition
Balloon kyphoplasty kitA collection of sterile surgical instruments and devices used for the reduction of a vertebral compression fractures (VCFs) caused by trauma, cancer, or osteoporosis during a minimally invasive procedure commonly known as balloon kyphoplasty. It typically consists of a bone access needle, an osteo introducer, an inflation syringe, and the inflatable bone tamp. This procedure involves the insertion of the balloon tamp into a patient's back to reduce a vertebral body fracture by compression of cancellous bone and/or movement of the endplates as the balloon is inflated, and filling the void created with orthopaedic cement/filler to stabilize the vertebra. This is a single-use device.

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
10884450413200StabiliT®Merit Medical Systems, Inc.NDN2026-03-11
10884450413217StabiliT®Merit Medical Systems, Inc.NDN2026-03-05
10884450587734StabiliT® Merit Medical Systems, Inc.NDN2026-02-19
10884450731700StabiliT®Merit Medical Systems, Inc.NDN2026-02-19
10884450731724StabiliT®Merit Medical Systems, Inc.NDN2026-02-19
10884450847296StabiliT®Merit Medical Systems, Inc.NDN2026-02-19
10884450847302StabiliT®Merit Medical Systems, Inc.NDN2026-02-19
10884450587772StabiliT®Merit Medical Systems, Inc.NDN2026-02-18
03701505801204DynamoTEKNIMEDNDN2026-02-02
03701505801211DynamoTEKNIMEDNDN2026-02-02
03701505801228DynamoTEKNIMEDNDN2026-02-02
03701505801235DynamoTEKNIMEDNDN2026-02-02
00197157026639ZAVATION ZVplasty Balloon CatheterZavation LLCNDN2025-07-08
00197157026646ZAVATION ZVplasty Balloon CatheterZavation LLCNDN2025-07-08
03701505801020PureKit Syringe 1.5cc MVTEKNIMEDNDN2025-03-31
03701505801037META+ System 1.5cc MVTEKNIMEDNDN2025-03-31
00815212026966OS 11G BONE FILLER KIT-OSTEOFIXIzi Medical Products, LLCNDN2025-03-26
00815212026942BKP-10-12.0-15.0-BIzi Medical Products, LLCNDN2025-01-08
00815212026959BKP-11-12.0-15.0-BIzi Medical Products, LLCNDN2025-01-08
00889095358230CONCORDGLOBUS MEDICAL, INC.NDN2024-12-01
00889095358247CONCORDGLOBUS MEDICAL, INC.NDN2024-12-01
00197157019334Zavation CURVED CURETTEZavation LLCNDN2024-11-13
00842166121546Zavation ZVplasty System AssemblyZavation LLCNDN2024-11-01
07613327638448OmnicurveSTRYKER CORPORATIONNDN2024-09-03
00815212026911KIT:BALLOON AND BONE FILLERIzi Medical Products, LLCNDN2024-08-28
00815212026928KIT:BALLOON,FILLER,ACCESS,DRILLIzi Medical Products, LLCNDN2024-08-28
10815212026895OsteoPearl Vertebral Balloon (15mm), 10GIzi Medical Products, LLCNDN2024-08-05
00815212026904OsteoPearl Vertebral Balloon (15mm) & Inflation Device Kit, 10GIzi Medical Products, LLCNDN2024-08-05
00197157019730ZavationZavation LLCNDN2024-07-01
00197157019747ZavationZavation LLCNDN2024-07-01