FDA.report

Vector

Primary DI
00810005669252
Company
NVISION BIOMEDICAL TECHNOLOGIES, INC.
Model
HAM-14-35
Device description
14mm long, 3.5mm diameter encoded 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
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Regulatory Flags

DUNS number
047486041
Device count
1
DM exempt
true
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
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Identifiers

IdentifierTypeAgencyPackage quantityStatus
00810005669252PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
00810005669252PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
HWCScrew, Fixation, Bone2Orthopedic888.3040YEligible

Premarket Submissions

No records found.

Premarket Details

No records found.

GMDN Terms

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

TypeValueText
Length14 Millimeter
Outer Diameter3.5 Millimeter

Storage And Handling

No records found.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
210-545-3713diana@nvisionbiomed.com

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00810135963275ImpactPP-1000T-4002025-09-22
00810135963381ImpactPP-1000T-2002025-09-22
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00810135963626ImpactPP-40-502025-09-22

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