FDA.report

Vector

Primary DI
00810005666732
Company
NVISION BIOMEDICAL TECHNOLOGIES, INC.
Model
HAM-15-35
Device description
Structurally encoded implant 15mm long, 3.5mm diameter. The Vector Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe.
Published
2019-11-30
Public version status
Update
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

Regulatory Flags

DUNS number
047486041
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
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00810005666732PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00810005666732PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
HWCScrew, Fixation, Bone2Orthopedic888.3040YEligible

Premarket Submissions

SubmissionSupplement
K183055000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K183055000Vector Hammertoe Correction SystemNvision Biomedical Technologies, LLC2019-02-19HWC

GMDN Terms

TermDefinition
Orthopaedic bone screw, non-bioabsorbable, sterileA small, sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). There are a number of kinds available: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression across bone fragments.

Device Sizes

TypeValueText
Length15 Millimeter
Outer Diameter3.5 Millimeter

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

PhoneEmail
210-545-3713diana@nvisionbiomed.com

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810005667227TrigonWD-1001T-WSLA2025-12-19
00810005668163VertexSTK-1000T-PIN2025-12-18
00810135964180VertexSTK-20-16-162025-12-17
00810135963268ImpactPP-1000T-0322025-09-24
00810135963282ImpactPP-1000T-0422025-09-24
00810135963329ImpactPP-1001T-CUT42025-09-24
00810135963374ImpactPP-1001T-CUT32025-09-24
00810135963404ImpactPP-1000T-DEP342025-09-24
00810135963411ImpactPP-1001T-SLAP2025-09-24
00810135963640ImpactKWIRE-14-127S2025-09-24
00810135963657ImpactINST-1000T-M2502025-09-24
00810135963336ImpactPP-1000T-3012025-09-23
00810135963343ImpactPP-1000T-4012025-09-23
00810135963169ImpactPP-1001T-3002025-09-22
00810135963183ImpactPP-1001T-4002025-09-22
00810135963251ImpactPP-1000T-3002025-09-22
00810135963275ImpactPP-1000T-4002025-09-22
00810135963381ImpactPP-1000T-2002025-09-22
00810135963619ImpactPP-30-502025-09-22
00810135963626ImpactPP-40-502025-09-22

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810211040227Headed Screw Partially Threaded Short 3.0mm,30mm LengthPace Surgical, Inc.HWC2026-03-19
08059386744369RONDO'CITIEFFE SRLHWC2026-03-17
00888867529038Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529083Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529090Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529113Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529144Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529151Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529182Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529212Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529373Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529434Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529441Arthrex®ARTHREX, INC.HWC2026-03-16
00888867529526Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531918Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531932Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531949Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531963Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531970Arthrex®ARTHREX, INC.HWC2026-03-16
00888867531987Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532007Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532069Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532083Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532137Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532144Arthrex®ARTHREX, INC.HWC2026-03-16
00888867532281Arthrex®ARTHREX, INC.HWC2026-03-16
04053613298315Guide Pin SmoothGebr. Brasseler GmbH & Co. KGHWC2026-03-11
00840124525474PolyLock MidfootFUSION ORTHOPEDICS, LLCHWC2026-03-10
00840124525481PolyLock MidfootFUSION ORTHOPEDICS, LLCHWC2026-03-10
00841506141442Distal Elbow Plating SystemSKELETAL DYNAMICS L.L.C.HWC2026-03-05