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Found 8 results
510(k) Data Aggregation
K Number
K230724Device Name
arcad® 2.0 Duo & Quadro osteosynthesis compressive staples
Manufacturer
Novastep
Date Cleared
2023-12-04
(263 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
Novastep
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
arcad® 2.0 Duo & Quadro osteosynthesis compressive staples are indicated for foot bone fragments osteotomy fixation and joint arthrodesis.
Device Description
arcad® 2.0 Duo & Quadro osteosynthesis compressive staple implants with two-leg and four-leg configurations with multiple bridge and leg lengths. The implants are manufactured from nickel-titanium alloy (ASTM F2063). The system is provided as a single-use sterile pack comprising of a bone staple implant ready to implant assembled in open legs position on its dedicated disposable insertor forceps and instruments for implantation. The implant is designed to facilitate bone fusion with Nitinol pseudoelastic behavior.
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K Number
K223468Device Name
Nexis® compressive screws
Manufacturer
Novastep
Date Cleared
2023-08-30
(286 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
Novastep
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nexis® compressive screws system is a single use device indicated for the fixation, correction or stabilization of bones and bone fragments of the foot and ankle in adult patients. The system is indicated for:
Ø5.0mm compressive screw:
- Os Calcis and talar fractures
- Calcaneus osteotomies
- Arthrodesis of the tarsals
Ø7.0mm compressive screw:
- Ankle arthrodesis
- Calcaneus osteotomies
Device Description
Nexis® is a range of osteosynthesis compressive single use screws, made of titanium alloy, designed to address foot and ankle indications. These devices are designed for stable fixation and have quick insertion features.
They are implantable medical devices intended to be used in orthopedics for foot and ankle surgery. The device is sold sterile. The shelf life is 5 years.
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K Number
K192356Device Name
Airlock Centrolock Osteosynthesis Implant System
Manufacturer
NOVASTEP
Date Cleared
2019-12-14
(107 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
NOVASTEP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Airlock® Centrolock® osteosynthesis implant systems are single-use devices intended for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hands, feet, ankle, fingers and toes.
Examples include:
- Mono or Bi-Cortical osteotomies in the foot or hand
- Distal or Proximal metatarsal or metacarpal osteotomies
- Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- Calcaneus/cuboid arthrodesis
- Talar/navicular arthrodesis
The system may be used in adult patients.
Device Description
Airlock® Centrolock® osteosynthesis implant systems are single-use bone fixation devices intended to be permanently implanted. implant systems are designed with different shapes and are made of Titanium (Alloy Ti-6Al-4V ELI). The system uses either 2mm cortical screws or 2,5mm locking screws. The drill holes are aligned to make sure there is no risk of conflict between the screws. The implant vary essentially through different curvatures and shapes.
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K Number
K151277Device Name
Airlock® osteosynthesis plate system
Manufacturer
NOVASTEP
Date Cleared
2015-08-13
(91 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
NOVASTEP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Airlock® osteosynthesis plate systems are indicated for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric patients.
Device Description
Airlock® osteosynthesis plate systems are single-use bone fixation devices intended to be permanently implanted. Plates are designed with different shapes and are made of Titanium (Alloy Ti-6Al-4V ELI). The system uses either 3mm or 3,5mm locking and non-locking screws. The drill hole are aligned to make sure there is no risk of conflict between the screws. The plates vary essentially through different curvatures, lengths, number of holes and shape.
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K Number
K143523Device Name
Airlock osteosynthesis plate system
Manufacturer
NOVASTEP
Date Cleared
2015-04-06
(115 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
NOVASTEP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Airlock® osteosynthesis plate systems are indicated for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric patients.
Device Description
Airlock® osteosynthesis plate systems are bone fixation devices intended to be permanently implanted. Plates are designed with different shapes and are made of Titanium (Alloy Ti-6Al-4V ELI). The system uses either 3mm or 3,5mm locking and non-locking screws. The drill hole are aligned to make sure there is no risk of conflict between the screws. The plates vary essentially through different curvatures, lengths, number of holes and shape.
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K Number
K143049Device Name
LYNC intramedullary implant
Manufacturer
NOVASTEP
Date Cleared
2015-02-19
(119 days)
Product Code
HTY
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
NOVASTEP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Lync® intramedullary implants are indicated for small bone reconstruction limited to inter-digital fusion of fingers and toes and small bone fusion.
Device Description
Lync® intramedullary implants are single-use bone fixation devices intended to be permanently implanted. Lync® intramedullary implants are made of unalloyed titanium.
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K Number
K143146Device Name
Nexis osteosynthesis snap-off screws
Manufacturer
NOVASTEP
Date Cleared
2015-02-06
(95 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
NOVASTEP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nexis® osteosynthesis compressive screws are single use devices indicated for the fixing and stabilizing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only.
Device Description
Nexis® osteosynthesis snap-off screws are single-use bone fixation devices intended to be permanently implanted. Nexis® osteosynthesis snap-off screws are non canulated snap-off screws made of Titanium (Alloy Ti-6Al-4V ELI). Nexis® osteosynthesis snap-off screws are non canulated snap-off bone screws which allow a permanent compression, thus supporting a secure osseous restoration.
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K Number
K143229Device Name
Nexis osteosynthesis compressive screws
Manufacturer
NOVASTEP
Date Cleared
2015-02-06
(88 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
NOVASTEP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Nexis® osteosynthesis compressive screws are single use devices indicated for the fixing and stabilizing the elective osteotomies of the mid foot bones and the metatarsal and phalanges of the foot only.
Device Description
Nexis® osteosynthesis compressive screws are single-use bone fixation devices intended to be permanently implanted. Nexis® osteosynthesis compressive screws are canulated compressive screws made of Titanium (Alloy Ti-6Al-4V ELI). Nexis® osteosynthesis compressive screws are compressive canulated bone screws which allow a permanent compression, thus supporting a secure osseous restoration.
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