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510(k) Data Aggregation
K Number
K133691Device Name
EXTRIMILOCK ANKLE PLATING SYSTEM
Manufacturer
OSTEOMED LP
Date Cleared
2014-02-24
(84 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
OSTEOMED LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OsteoMed ExtremiLOCK Ankle Plating System is intended for fixation of fractures, arthrodesis, osteotomies, and non-unions of the tibia and fibula. The ExtremiLOCK Ankle Plating System implants are intended for single use only.
The 1/3 tubular plates, hook plates, screws, and washers are also intended for use in trauma, general surgery, and reconstructive procedures of bones appropriate for the size of the device.
The OsteoMed ExtremiLOCK Ankle Plating System can be used for adult and pediatric patients.
Device Description
The OSTEOMED ExtremiLOCK Ankle Plating System is a comprehensive ankle fracture system intended to provide solutions for various bony fractures, including simple to complex fractures of the distal tibia and fibula. The plates are provided in a variety of shapes and sizes, offering surgeons compression, non-locking and locking hole designs. The ExtremiLOCK Ankle Plating System includes angulated locking screws and standard non-locking screws as well as K-wires. Surgical instrumentation is provided to facilitate insertion, modification and/or removal of implants.
The implants of the OsteoMed ExtremiLOCK Ankle Plating System are made from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136). The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.
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K Number
K131445Device Name
OSTEOMED EXTREMILOCK FOOT PLATING SYSTEM
Manufacturer
OSTEOMED LP
Date Cleared
2013-06-18
(29 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
OSTEOMED LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OsteoMed ExtremiLOCK Foot Plating System is indicated for use in trauma, general surgery, and reconstructive procedures of the foot, ankle or other bones appropriate for the size of the device.
The OsteoMed ExtremiLOCK Foot Plating System implants are intended for single use only.
Device Description
The OsteoMed ExtremiLOCK Foot Plating System consists of plates of various shapes and sizes featuring compression, locking, elongated or compression elongated holes, angulated locking, non-locking and cannulated screws, implantable K-Wires, washers, and appropriate instrumentation. Modifications to plates of the subject system include increasing the thickness of the plates, material changes, and addition of features.
The implants of the OsteoMed ExtremiLOCK Foot Plating System are made from Titanium (ASTM F-67) or Titanium alloy (ASTM F-136), Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. The instrumentation is made from various grades of stainless steel, anodized aluminum, and/medical grade polymer.
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K Number
K123885Device Name
OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR
Manufacturer
OSTEOMED LP
Date Cleared
2013-06-03
(167 days)
Product Code
PBJ, JEY, MQN
Regulation Number
882.5330Why did this record match?
Applicant Name (Manufacturer) :
OSTEOMED LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OsteoMed smartflex Cranial Spring Distraction System is intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated. This device is intended to provide temporary stabilization and gradual lengthening of the cranial bones. This device is intended to be removed after consolidation. The OsteoMed smartflex Cranial Spring Distraction System is intended for single patient use only.
Device Description
The OsteoMed smartflex Cranial Spring Distraction System is a distraction osteogenesis system consisting of distractors in various sizes. The distractor is anchored to the cranium by the distractor foot plate. The distractor gradually distracts the bone segments by applying a continuous force to the bones of the skull facilitating remodeling to expand the prematurely closed suture. The distractors are removed after consolidation. The instruments used with the system are pliers, benders, plate cutters and other instruments to facilitate the placement and removal of the OsteoMed smartflex cranial spring distractors. The OsteoMed smartflex Cranial Spring Distractors are made from Medical Grade Stainless Steel per ASTM F-138.
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K Number
K123207Device Name
PRIMALIF TM LLIF UNITARY PEEK LATERAL LUMBAR INTERBODY FUSION SYSTEM
Manufacturer
OSTEOMED LP
Date Cleared
2012-11-29
(48 days)
Product Code
MAX
Regulation Number
888.3080Why did this record match?
Applicant Name (Manufacturer) :
OSTEOMED LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PrimaLIFTM LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System (PrimaLIFTM LLIF) is indicated for intervertebral body fusion of the lumbar spine to be used with autogenous bone graft, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) and these patients may have up to Grade I spondylolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation systems such as PrimaLOK™ SP and PrimaLOK™ FF which have been cleared for use in the lumbar spine.
The PrimaLIFTM LLIF implants are intended for single use only.
Device Description
The PrimaLIFTM LLIF Unitary PEEK Lateral Lumbar Interbody Fusion System is a comprehensive interbody cage system that provides structural stability of the anterior column. It is comprised of unitary PEEK interbody cages of various sizes. The instruments provided with the system include osteoteomes, implant trials, and an inserter to facilitate placement of the interbody device.
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K Number
K120015Device Name
OSTEOMED WRIST PLATING SYSTEM
Manufacturer
OSTEOMED LP
Date Cleared
2012-04-24
(112 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
OSTEOMED LP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OsteoMed Wrist Plating System is intended for fracture fixation, fusion and osteotomies of wrist and other bones appropriate for the size of the device. It is intended for use in trauma, general surgery and reconstructive procedures.
OsteoMed Wrist Plating System implants are intended for single use only.
Device Description
The OsteoMed Wrist Plating System is a rigid fixation and fusion system , consisting of plates and screws in various configurations along with the appropriate instrumentation to facilitate modification, implantation, or removal of the implants. Plates are anatomically pre-contoured in various shapes and sizes. Screws are provided with variable angle locking or non-locking head in various lengths. These screws are either solid core or cannulated and can be used with or without plates.
Plates and screws are supplied in a variety of configurations. The plates and screws are made of titanium alloy (ASTM F136). K-wires are made of titanium alloy (ASTM F136) or stainless steel (ASTM F138). The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.
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