FDA.reportPublic FDA data

Vector

Primary DI
00810005660952
Brand
Vector
Company
NVISION BIOMEDICAL TECHNOLOGIES, INC.
Model
HAM-14-35C
Device description
14mm long, 3.5mm diameter Cannulated Hammertoe Implant (Steam). 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
2022-01-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201850000
K213421000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201850000Vector Hammertoe Correction SystemNvision Biomedical Technologies, Inc.2020-08-04HWC
K213421000Vector® Hammertoe Correction SystemNvision Biomedical Technologies, Inc.2021-11-19HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810005660952PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810005660952008100056609528100056609520810005660952

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone pin, non-bioabsorbableA small diameter rod typically used for the fixation of a bone fracture or bone grafts, or for an osteotomy or arthrodesis. The rod may be smooth, wholly- or partially-threaded, solid or cannulated, and some designs may be tapered; it is not specific to the clavicle bone. The device is made of a material that is not chemically degraded or absorbed by natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). Some designs may have a break-off shank and/or may be coated [e.g., with hydroxyapatite, also known as hydroxylapatite (HA)] to improve purchase in osteoporotic bone and for long-term fixation. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length14Millimeter
Outer Diameter3.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
210-545-3713diana@nvisionbiomed.com

Regulatory Flags#

DUNS number
047486041
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810005668088TrigonWD-1001C-7002026-04-24
00810005668095TrigonMTP-22-08-002026-04-24
00810005668101TrigonMTP-22-10-002026-04-24
00810005668118TrigonMTP-22-12-002026-04-24
00810005668125TrigonWD-1000T-MWIS2026-04-24
00810005668187TrigonMTP-18-08-002026-04-24
00810135963565TrigonMTP-18-10-002026-04-24
00810135963572TrigonMTP-18-12-002026-04-24
00810005668132TrigonMTP-22-08T-002026-04-23
00810005668149TrigonMTP-22-10T-002026-04-23
00810005668156TrigonMTP-22-12T-002026-04-23
00810135963589TrigonMTP-18-08T-002026-04-23
00810135963596TrigonMTP-18-10T-002026-04-23
00810135963602TrigonMTP-18-12T-002026-04-23
00810135960502Retropsoas ElectrodeELEC1000-042023-10-25
00810135960519Retropsoas ElectrodeELEC1000-062023-10-25
00810135960526Retropsoas ElectrodeELEC1000-082023-10-25
00810135960533Retropsoas ElectrodeELEC1000-102023-10-25
00810135960540Retropsoas ElectrodeELEC21002023-10-25
00810135960557Retropsoas ElectrodeELEC22402023-10-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569658212Xpert PFPNEWCLIP TECHNICSHWC2026-06-03
00842188131981CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132063Tools - HCSTrimed, INC.HWC2026-06-02
00842188132070Tools - HCSTrimed, INC.HWC2026-06-02
07630894829819APTUSMedartis AGHWC2026-06-01
07630894829826APTUSMedartis AGHWC2026-06-01
07630894829833APTUSMedartis AGHWC2026-06-01
07630894829840APTUSMedartis AGHWC2026-06-01
07630894829857APTUSMedartis AGHWC2026-06-01
07630894829864APTUSMedartis AGHWC2026-06-01
07630894829871APTUSMedartis AGHWC2026-06-01
07630894829888APTUSMedartis AGHWC2026-06-01
07630894829895APTUSMedartis AGHWC2026-06-01
07630894829901APTUSMedartis AGHWC2026-06-01
07630894829918APTUSMedartis AGHWC2026-06-01
07630894829925APTUSMedartis AGHWC2026-06-01
07630894829932APTUSMedartis AGHWC2026-06-01
07630894829949APTUSMedartis AGHWC2026-06-01
07630894829956APTUSMedartis AGHWC2026-06-01
07630894829963APTUSMedartis AGHWC2026-06-01
07630894829970APTUSMedartis AGHWC2026-06-01
07630894829987APTUSMedartis AGHWC2026-06-01
07630894829994APTUSMedartis AGHWC2026-06-01