FDA.reportPublic FDA data

Winch Kyphoplasty Kit 8G 20 mm

Primary DI
08058964727787
Brand
Winch Kyphoplasty Kit 8G 20 mm
Company
G21 SRL
Model
900208
Published
2025-02-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRXArthroscope
NDNCement, Bone, Vertebroplasty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRXArthroscopeOrthopedic2
NDNCement, Bone, VertebroplastyOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172214000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172214000Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon CathetersG-21 S.R.L.2017-08-23NDN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08058964727787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08058964727787080589647277878058964727787

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
431529195
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08058964729163KeyFix_FILLER CANNULA FOR FENESTRATED SCREW 8-16 G9000302026-05-05
08058964729057Arthrex Bone Cement Closed Mixing Bowl AS-901-22024-10-14
08058964729064Arthrex Bone Cement Mixing Syringe AS-901-32024-10-14
08058964729071Arthrex Bone Cement Syringe Gun, DisposableAS-901-42024-10-14
08058964727862SpaceFlex Knee Trial9002012024-10-10
08058964728654Arthrex Bone Cement Mixing Syringe AR-901-32024-10-14
08058964728715Arthrex Bone Cement Open Mixing BowlAR-901-12024-10-14
08058964728753Arthrex Bone Cement Closed Mixing Bowl AR-901-22024-10-14
08058964728760Arthrex Bone Cement Syringe Gun, DisposableAR-901-42024-10-14
08058964729217CeMend Shoulder SpacerAR-902-08422025-12-19
08058964729224CeMend Shoulder SpacerAR-902-10422025-12-19
08058964729231CeMend Shoulder SpacerAR-902-10482025-12-19
08058964729248CeMend Shoulder SpacerAR-902-12482025-12-19
08058964729255CeMend Shoulder Spacer Reamer TrayAR-902-C12025-12-19
08058964729262Reamer T-handleAR-902-132025-12-19
08058964729279CeMend Reamer 8mmAR-902-142025-12-19
08058964729286CeMend Reamer 10mmAR-902-152025-12-19
08058964729293CeMend Reamer 12mmAR-902-162025-12-19
08058964729309CeMend Reamer 14mmAR-902-172025-12-19
08058964729385CeMend Shoulder Spacer Trial 08 42AR-902-202025-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00846338007140BiPolar Cable, DisposableELLIQUENCE, LLCHRX2026-06-02
00846338005146Neutral PlateELLIQUENCE, LLCHRX2026-06-01
00846338005320Needle PunchELLIQUENCE, LLCHRX2026-06-01
07613327601695Connected OR HubSTRYKER CORPORATIONHRX2025-06-04
07613327601701SDC4K Information Management SystemSTRYKER CORPORATIONHRX2025-06-04
08058964726452Winch Kyphoplasty Kit 15 mmG21 SRLNDN2025-02-26
08058964726469Winch Kyphoplasty Kit 20 mmG21 SRLNDN2025-02-26
08058964726735Winch Kyphoplasty Bilateral Kit 15 mmG21 SRLNDN2025-02-26
08058964727589EasyWinch 15 mmG21 SRLNDN2025-02-26
08058964727596EasyWinch 20 mmG21 SRLNDN2025-02-26
08058964727763Winch Kyphoplasty Kit 8G 15 mmG21 SRLNDN2025-02-26
08058964727770Winch Kyphoplasty Bilateral Kit 8G 15 mmG21 SRLNDN2025-02-26
08058964727794Winch Kyphoplasty Bilateral Kit 8G 20 mmG21 SRLNDN2025-02-26
08058964727817Winch Kyphoplasty Bilateral Kit 20 mmG21 SRLNDN2025-02-26
07613327545258AutoPlex VertaPlexSTRYKER CORPORATIONNDN2024-11-21
07613327638226OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638233OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638240OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638257OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638431OmnicurveSTRYKER CORPORATIONNDN2024-09-03
07613327638448OmnicurveSTRYKER CORPORATIONHRX2024-09-03
08033860030179BIOPSYBELLBIOPSYBELL SRLNDN2024-02-26
08033860023966BIOPSYBELLBIOPSYBELL SRLNDN2024-01-11
08033860023980BIOPSYBELLBIOPSYBELL SRLNDN2024-01-11
08033860024000BIOPSYBELLBIOPSYBELL SRLNDN2024-01-11
07613327554724OmnicurveSTRYKER CORPORATIONNDN2023-11-07
07613327554649OmnicurveSTRYKER CORPORATIONHRX2023-11-02
08033860030186BIOPSYBELLBIOPSYBELL SRLNDN2023-06-12
08033860030193BIOPSYBELLBIOPSYBELL SRLNDN2023-06-12
08033860037826BIOPSYBELLBIOPSYBELL SRLNDN2023-06-12