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510(k) Data Aggregation
K Number
K102601Device Name
ORTHOFLEX ROD
Manufacturer
ORTHO-PRO LLC
Date Cleared
2011-01-14
(127 days)
Product Code
KWH
Regulation Number
888.3720Why did this record match?
Applicant Name (Manufacturer) :
ORTHO-PRO LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The indications for the OrthoFlex Rod include:
- Semi-rigid or rigid hammertoe deformity associated with degenerative arthritis
- Semi-rigid or rigid hammertoe deformity associated with rheumatoid arthritis
- Revision of a failed arthroplasty or arthrodesis
Device Description
The OrthoFlex Rod design is a double-stemmed flexible implant designed for the proximal interphalangeal joint of the lateral toes. It is made of silicone elastomer, and is constructed in a rod-shaped design with a thicker mid-section spacer or collar.
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K Number
K094037Device Name
TC PLATING SYSTEM
Manufacturer
ORTHO-PRO LLC
Date Cleared
2010-03-10
(70 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
ORTHO-PRO LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TC Plating System is intended for essentially non load-bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton.
Device Description
The TC Plating System is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. The plates include straight, right, and left configurations. The system also includes bone screws. Manual surgical instruments are supplied with the system to facilitate implantation.
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K Number
K042310Device Name
ORTHO-PRO CANNULATED BONE SCREWS
Manufacturer
ORTHO-PRO LLC
Date Cleared
2004-09-16
(22 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
ORTHO-PRO LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ortho-Pro Cannulated Bone Screws are indicated for bone fractures, osteotomies, artrhodeses, osteochronditis and tendon reattachment.
These screws are not intended for attachment or fixation to the posterior elements (pedicles) of the cervical, thoracic or lumbar spine.
Device Description
The Ortho-Pro Cannulated Bone Screw consists of a threaded implant and corresponding instrumentation to facilitate insertion. The implants are cylindrical in shape and incorporate a center cannula designed for use with a guide wire to facilitate proper placement of the implant. An internal hex-head allows for maximum torque with minimal risk of stripping. These screws are of the self-tapping type. This device is manufactured from Ti-6A1-4V alloy and is available in a variety of sizes.
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K Number
K032682Device Name
STS SCREW
Manufacturer
ORTHO-PRO LLC
Date Cleared
2003-10-22
(54 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
ORTHO-PRO LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ortho-Pro STS Screw is indicated for use in treatment of the hyperpronated foot and stabilization of the subtalar joint. It is designed to block the posterior and inferior displacement of the talus, thus allowing normal subtalar joint motion while blocking excessive pronation and the resulting sequela. It is appropriate for the following conditions:
- Severely pronated foot
- Walking intemperance
- Calcaneal stance position greater than 5°
- Manually correctable deformities
- Mid-tarsal breech (arch pain)
- Forefoot varus greater than 10°
Device Description
The Ortho-Pro STS Screw consists of a threaded implant, designed to be inserted between the posterior and middle facets of the subtalar joint and corresponding instrumentation to facilitate insertion. The implant is cylindrical in shape and incorporates a center cannula designed for use with a guide wire to facilitate proper placement of the implant. An internal hex-head allows for maximum torque with minimal risk of stripping. External rounded threads increase ease of insertion. This device is manufactured from Ti-6A1-4V alloy and is available in six sizes, 06.5mm to Ø11.5mm in 1mm increments.
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