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510(k) Data Aggregation
K Number
K971457Device Name
BRYAN POSTERIOR SPINAL FIXATOR (BPSF), MODIFIED
Manufacturer
ARCAN ORTHOPAEDIC CORP.
Date Cleared
1997-07-16
(110 days)
Product Code
KWP
Regulation Number
888.3050Why did this record match?
Applicant Name (Manufacturer) :
ARCAN ORTHOPAEDIC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
When used as a hook, rod, and ileo-sacral screw fixation system (KWP) TI-S1, the indications for use are:
- spondylolisthesis
- fracture
- spinal stenosis
- deformities(scoliosis, kyphosis, lordosis)
- pseudarthrosis
- tumor
- multi-operated back or revision of previous surgery
The system is indicated for pedicle screw fixation (MNH) L3-S1, ilium as follows:
When used as a pedicle screw fixation system the device system is intended for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine; and (d) who are having the device removed after the development of a solid fusion mass.
Device Description
The Contour Spinal Fixation System consists of rods, hooks, screws, clamps, and plates designed for attachment to the noncervical spine to restore or maintain the normal alignment and assist in obtaining arthrodesis of abnormal vertebral motion segments. The implants are made of 22-13-5 stainless steel conforming to ASTM-138. Three types of rods pre-cut to a variety of lengths are provided. The first rod is a simple straight rod. The second has a right angle bend with a short arm on one end. The third has an expansion with a screw hole on one end. The system uses three types of clamps. One clamp consists of and eye-bolt-"C" shaped clamp combination which connects longitudinal rods with a crosslink rod. A second clamp is shaped like a "C" which encircles and is compressed to the rod by the proximal threads of a bone screw engaging and lagging the threaded side of holes placed through the ends of the "C". The third clamp is similar to the second clamp except the compressing screw is a simple screw which is also used to attach a crosslink plate. Extending from and incorporated as part of the third clamp is a short rod. which, when connected to a "C" clamp-bone screw combination, allows insertion of a bone screw in any horizontal or sagital angle or translational distance from a longitudinal rod. The system has two types of screws provided in a variety of lengths. One screw locks to the rod by engaging the threads of a rod with a threaded hole expansion at one end or by the proximal threads of the screw lagging and compressing a "C" clamp around a rod . The second screw is secured by an eye-bolt in the head of the screw. Two mechanisms are used for hook-rod connection. One locks to the rod with an eye-bolt. The second has a lateral facing "U" shaped opening for the rod entrance. The rod is pushed into and locked at the closed end of the "U" by a tapered locking screw.
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K Number
K955927Device Name
BRYAN POSTERIOR SPINAL FIXATOR (MODIFICATION)
Manufacturer
ARCAN ORTHOPAEDIC CORP.
Date Cleared
1996-03-13
(82 days)
Product Code
KWP
Regulation Number
888.3050Why did this record match?
Applicant Name (Manufacturer) :
ARCAN ORTHOPAEDIC CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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