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510(k) Data Aggregation
K Number
K151708Device Name
RECON system - Compression Screws
Manufacturer
NORMED MEDIZIN-TECHNIK GMBH
Date Cleared
2016-03-02
(252 days)
Product Code
HWC, DEV, HTN
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
NORMED MEDIZIN-TECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The implants are intended to support normal bone healing for osteotomies, non-unions and reconstructions.
The RECON system consists of various system components and it is indicated for the treative fixation, nonunions, joint decompression and fusion, osteotomies, reconstruction or arthrodeses of bones. The system can be used in adult patients. Additional information is provided in the corresponding surgical techniques.
Device Description
The RECON system -compression screws are intended for internal fracture fixation. The system consists of the following screws:
- Microcan 1.8/2.3 ●
- . Maxican 4.5
- CBS Micro Compression ●
- CBS High Compression
- CBS 4.5/7.5 ●
- V-TEK Micro 2.0 ●
- V-TEK Standard 3.0 ●
screws of different sizes and designs.
The screws and washers are made of titanium alloy Ti-6AI-4V (ASTM F136).
The implants are offered in various sizes to accommodate the variations of bone size and geometry as well as plate sizes and configurations.
The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable.
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K Number
K151701Device Name
Tenodesis screw system
Manufacturer
NORMED MEDIZIN-TECHNIK GMBH
Date Cleared
2016-01-26
(216 days)
Product Code
HWC, MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
NORMED MEDIZIN-TECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tenodesis screws are intended for soft tissue reattachment procedures in foot surgery.
The system is indicated for soft tissue reattachment procedures in foot surgery, such as tendon reconstructions and tendon transfers.
The system can be used in adult patients. Additional information is provided in the corresponding surgical techniques.
Device Description
The Tenodesis screw system is intended for soft tissue reattachment procedures in foot surgery. The screws are made of titanium alloy Ti-6AI-4V (ASTM F136). They are threaded, fully cannulated anchors.
The implants are offered in various sizes. The implants are provided non-sterile and single-use only.
The Tenodesis instruments are non-sterile and reusable.
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K Number
K152256Device Name
RECON system- Grubber Lapidus-, Platar Lapidus-, Tarsalis Plates and Screws
Manufacturer
NORMED MEDIZIN-TECHNIK GMBH
Date Cleared
2015-11-05
(87 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
NORMED MEDIZIN-TECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.
The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. The system can be used in both adult and pediatric patients. Additional information is provided in the corresponding surgical techniques.
Gruber Lapidus
The Gruber Lapidus Plates 2.7 combined with the Standard/Locking/ MiniCAN screws 2.7 are indicated for TMT I joint arthrodesis with cuneiforme transfixation for correction of hallux valgus deformity.
Plantar Lapidus
The Plantar Lapidus Plates 2.7 combined with the Standard/Locking Screws 2.7 and the MiniCAN screws 3.5 are indicated for TMT I joint arthrodesis.
Tarsalis
The Tarsalis Plates 2.7 combined with the Standard/Locking Screws 2.7 are indicated for Lisfranc fusions and fracture fixation of the forefoot and midfoot.
Device Description
The RECON system – Gruber Lapidus-, Plantar Lapidus-, Tarsalis Plates and Screws is a plate and screw system intended for internal fixation. The system consists of the following plates and screws:
- Gruber Lapidus Plates 2.7, .
- . Plantar Lapidus Plates 2.7,
- Tarsalis Plates 2.7, ●
- Locking Screws 2.7 ●
- Standard Screws 2.7
- Minican Screws 2.7/3.5
of different sizes and designs.
The plates and screws are either made of titanium alloy Ti-6AI-4V (ASTM F136) or commercially pure Titanium (C.P. Titanium; ASTM F67).
The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable or for single use.
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K Number
K152312Device Name
RECON system-V-TEK-IVP Plates and Screws
Manufacturer
NORMED MEDIZIN-TECHNIK GMBH
Date Cleared
2015-10-30
(74 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
NORMED MEDIZIN-TECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The implants are intended to support normal bone healing for osteotomies, fractures, non-unions and reconstructions.
The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, non-unions, joint decompression and fusion, osteotomies, reconstruction or arthrodeses of bones. The system can be used in both adult and pediatric patients.
Device Description
The RECON system – V-TEK-IVP Plates and Screws is a plate and screw system intended for internal fixation. The system consists of the following plates and screws:
- V-TEK™ IVP Micro XS Plate 2.7, ●
- V-TEK™ IVP S Plate 2.7, .
- V-TEK™ IVP S. L-Plate 2.7 .
- . V-TEK™ IVP M Plate 2.7
- V-TEK™ IVP M Plate 3.5 .
- . V-TEK™ IVP L Plate 2.7
- V-TEK™ IVP L Plate 2.7 / 3.5
- . Titanium Screw Fully Treaded 2.7/3.5
of different sizes and designs.
The plates and screws are made of titanium alloy Ti-6AI-4V (ASTM F136).
The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable or for single use.
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K Number
K152142Device Name
RECON system - MPJ-Plates
Manufacturer
NORMED MEDIZIN-TECHNIK GMBH
Date Cleared
2015-09-16
(44 days)
Product Code
HRS, DEV
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
NORMED MEDIZIN-TECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.
The RECON system – MPJ Plates consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. The system can be used for adult patients. Additional information is provided in the corresponding surgical techniques.
MP-Joint Fusion Plates 2.7
The MP-Joint Fusion Plates 2.7 combined with the Standard/Locking Screws 2.7 are indicated for the arthrodesis of the first metatarso-phalangeal joint.
- Plate size S is indicated for standard MP-Joint fusions.
- . Plate Sizes M/L are indicated for standard MP-Joint fusion and interpositioning / revision fusions with bone graft (f.e. for revision of Keller-Brandes).
Universal Reconstruction Plates 2.7
The Universal Reconstruction Plates 2.7 combined with Standard/Locking Screws 2.7 are indicated for revision of MP-joint fusion and for reconstruction procedures in forefoot and midfoot.
docPrice Revision Plates 2.7/3.5
The docPrice Revision Plates 2.7/3.5 combined with the Standard/Locking Screws 2.7/3.5 are indicated for MTP I lengthening osteotomy and/or arthrodesis, especially indicated for cases of Keller-Brandes revisions, revisions after MTP I prosthesis and lengthening of short first toe.
Device Description
The RECON system – MPJ plates is a plate system intended for internal fracture fixation. The system consists of the following plates:
- MP - Joint Fusion Plates 2.7,
- . Universal Reconstructions Plates 2.7,
- . docPrice Revision Plates 2.7/3.5
of different sizes and designs.
The plates are either made of titanium alloy Ti-6Al-4V (ASTM F136) or commercially pure Titanium (C.P. Titanium; ASTM F67).
The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable or for single use.
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K Number
K151407Device Name
RECON system
Manufacturer
NORMED MEDIZIN-TECHNIK GMBH
Date Cleared
2015-08-12
(78 days)
Product Code
HRS, HTN, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
NORMED MEDIZIN-TECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The implants are intended to support normal bone healing for osteotomies, fractures, and reconstructions.
The RECON system consists of various system components and it is indicated for the treatment of fracture fixation, joint decompression and fusion, reconstruction or arthrodeses of small bones. The system can be used in both adult and pediatric patients. Additional information is provided in the corresponding surgical techniques.
Device Description
The RECON system is a plate and screw system intended for internal fracture fixation. The system consists of the following plates:
- Reconstruction Plates 3.5, ●
- Medialis Plates 3.5, ●
- Universal Plates 3.5
- Universal Plates 3.5, H-shaped .
- USG Plates 3.5 ●
- Interpositioning Arthrodesis Plates ●
- Lapidus Plates ●
- . Dwyer Plates
screws and washers of different sizes and designs.
The plates, screws, and washers are either made of titanium alloy Ti-6AI-4V (ASTM F136) or commercially pure Titanium (C.P. Titanium; ASTM F67).
The implants are offered in various sizes to accommodate the variations of bone size and geometry. The implants are provided non-sterile and single-use only. The instruments are non-sterile and reusable.
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K Number
K133035Device Name
NORMED PELLEGRIN CALCANEUS STOP SCREW
Manufacturer
NORMED MEDIZIN-TECHNIK GMBH
Date Cleared
2013-12-13
(77 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
NORMED MEDIZIN-TECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Normed® Pellegrin Calcaneus Stop Screw System is indicated for adult, children and adolescent patients. The screws are intended to block forward and medial displacement of the allowing normal subtalar joint motion but blocking excessive pronation and the resulting sequela. Adult - additive subtalar alignment for flat foot. Children - flexible flat foot treatment in children and adolescents
Device Description
The Normed Pellegrin Calcaneus Stop Screws are threaded, cannulated, tapered screws. They designed to be inserted into the calcaneus bone of the foot for subtalar arthoroereisis. They are made from CrNiMO Stainless Steel for Surgical Implants (ASTM F138. ISO 58321). The implant is offered in 3 lengths - 25mm, 30mm and 35mm. The implants are provided non-sterile and singleuse only. The instruments are non-sterile and reusable.
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K Number
K123347Device Name
NORMED ANKLE FIX SYSTEM 4.0 AND NORMED ANKLE FIX PLUS SYSTEM 4.0
Manufacturer
NORMED MEDIZIN-TECHNIK GMBH
Date Cleared
2013-08-02
(275 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
NORMED MEDIZIN-TECHNIK GMBH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ANKLE FIX and ANKLE FIX + Systems 4.0 are indicated for:
- · skeletal osteosynthesis of small bone fragments, which were damaged due to trauma or require reconstruction or arthrodesis
- · primary or revision tibio-talar and tibiotalo-calcaneal fusion especially in the presence of osteopenic bone, hindfoot deformity and bone loss
- · post-traumatic surgery.
Device Description
The Normed ANKLE FIX and ANKLE FIX + Systems 4.0 are titanium plate and screw systems intended for internal fracture fixation of the ankle. The pre-contoured plates are anatomically designed for optimal screw positioning. This trauma system offers lateral plates for fusion of the tibiotalar (ANKLE FIX) and tibiotalo-calcaneal (ANGLE FIX +) bones as well as medial, posterior (hindfoot), posterior tibia and anterior plates as needed for the ankle for stability.
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