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510(k) Data Aggregation
K Number
K151004Device Name
PULLUP® Adjustable Juxtacortical Fixation Device
Manufacturer
SBM SCIENCES FOR BIO MATERIALS
Date Cleared
2015-11-17
(216 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
SBM SCIENCES FOR BIO MATERIALS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PULLUP® device is designed to be used as juxtacortical fixation for ACL reconstruction.
Device Description
The PULLUP® Adjustable Juxtacortical Fixation Device consists of an adjustable nonabsorbable braided loop and titanium button. The system is preloaded with traction threads. The PULLUP® Adjustable Juxtacortical Fixation Device is available in 2 versions: -PULLUP® for cortical tunnels having a diameter of 4.5 mm - PULLUP®XL for cortical tunnels having a diameter between 5 and 10 mm - The implant is supplied sterile, ready to use.
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K Number
K130953Device Name
NEOTIS; NEOTIS 50
Manufacturer
SBM SCIENCES FOR BIO MATERIALS
Date Cleared
2013-07-15
(101 days)
Product Code
MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
SBM SCIENCES FOR BIO MATERIALS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BIOSORB Resorbable Bone Void Filler is a resorbable calclum salt bone void filler intended to fill bony voids or gaps of the skeletal system (i.e. the extremities, posterolateral spine and pelvis,) caused by trauma or surgery, that are not intrinsic to the stability of the bony structure. BIOSORB Resorbable BoneVoid Filler does not possess sufficient mechanical strength to support reduction of a defect prior to soft and hard tissue ingrowth. Rigid fixation techniques are recommended as needed to assure stabilization of the defect in all plans.
In addition, when used with appropriate opening osteotomy system devices, plates and screws, BIOSORB Resorbable Bone Void Filler Is Intended to be used as a bone void filler in tiblal osteotomies.
Device Description
BIOSORB bone void filler (K021963 and K071155) is an osseo-conductive macroporous implant made of synthetic beta tri Calcium Phosphate (βΤCP) indicated for Bone Void Filling.
BIOSORB bone void filler presents a multidirectional interconnected porosity structure, similar to that of the human cancellous bone. BIOSORB bone void filler implant slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues.
To better fit the surgeon's needs and surgical preferences and patient's anatomy the full range of BIOSORB RESORBABLE BONE VOID FILLER will comprise:
- 9 shapes: stick, granule, cube, block (6 shapes) o
- 3 material specifications: BIOSORB 30, BIOSORB 45 and BIOSORB 70 o
- 3 packaging: box, vial, syringe 0
The design modifications of the new NEOTIS set of wedges with respect to OTIS set of wedges include a sharper anterior area and a wider posterior area more fitting the natural tibia anatomy. 3 letters are printed to help the surgeon with the wedge orientation: A stands for Anterior, M stands for Medial and P for Posterior.
There are 50 NEOTIS parts instead of 10 OTIS parts, so that the range is increased.
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K Number
K122228Device Name
LIGAFIX INTERFERENCE SCREW
Manufacturer
SBM SCIENCES FOR BIO MATERIALS
Date Cleared
2012-10-03
(69 days)
Product Code
MAI
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
SBM SCIENCES FOR BIO MATERIALS
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LIGAFIX® / ComposiTCP® is a cannulated, sterile, single-use, resorbable interference bone screw made of a mixture of tri calcium phosphate (beta-TCP) and Poly Lactic Acid (PLA) designed for the interference fixation of grafts in anterior cruciate ligament reconstruction.
Device Description
LIGAFIX / ComposiTCP range of products consists of resorbable cannulated screws available in several models designed for the interference fixation of grafts in anterior cruciate ligament reconstruction. LIGAFIX / ComposiTCP interference bone screw is made of a ceramic (beta-TCP) / polymer (Poly Lactic Acid -PLA) composite. LIGAFIX / ComposiTCP interference screw is available in several sizes and in two beta-TCP/ PLA ratios 60/40 (LIGAFIX 60/ ComposiTCP 60) and 30/70 (LIGAFIX 30/ ComposiTCP 30). LIGAFIX / ComposiTCP interference bone screws are supplied sterile and individually packaged in double heat sealed pouches. The purpose of this 510(k) was to address modifications to the head of certain screw configurations, along with modifications to the cannula to allow use with 1.1mm guide wire. The subject system offers screws in diameters ranging from 7 mm to 12 mm with lengths ranging from 20 mm to 35 mm.
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