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510(k) Data Aggregation
K Number
K150621Device Name
OsteoSelect PLUS Demineralized Bone Matrix Putty
Manufacturer
BACTERIN INTERNATIONAL INC.
Date Cleared
2015-08-18
(160 days)
Product Code
MQV, MBP
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
BACTERIN INTERNATIONAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OsteoSelect® PLUS DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony structure. OsteoSelect® PLUS DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect® PLUS DBM Putty can be used as follows:
- Extremities ●
- . Pelvis
- Posterolateral spine ●
Device Description
OsteoSelect® PLUS DBM Putty is processed human bone that has been demineralized and combined with an absorbable carrier that is biocompatible and biodegradable. The combination of demineralized bone and the absorbable carrier results in a putty-like consistency for ease and flexibility of use during surgical application. The carrier material is a mixture of carboxymethylcellulose (a wax-like material) and phosphate buffered saline (a dispersing agent). OsteoSelect® PLUS DBM Putty is virtually odorless, tan in color and can be spread easily with minimal adhesion to surgical gloves.
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K Number
K130498Device Name
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
Manufacturer
BACTERIN INTERNATIONAL INC.
Date Cleared
2013-05-31
(94 days)
Product Code
MBP, MQV
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
BACTERIN INTERNATIONAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OsteoSelect® DBM Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps that are not intrinsic to the stability of the bony strtucture. OsteoSelect® DBM Putty is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone. OsteoSelect® DBM Putty can be used as follows: - Extremities . - Posterolateral spine - Pelvis
Device Description
OsteoSelect® DBM Putty is processed human bone that has been demineralized and combined with an absorbable carrier that is biocompatible and biodegradable. The combination of demineralized bone and the absorbable carrier results in a putty-like consistency for ease and flexibility of use during surgical application. The carrier material is a mixture of carboxymethylcellulose (a wax-like material) and phosphate buffered saline (a dispersing agent). OsteoSelect® DBM Putty is virtually odorless, tan in color and can be spread easily with minimal adhesion to surgical gloves. OsteoSelect® DBM Putty is intended for use as a filler for voids or gaps that are not intrinsic to the stability of the bony structure. The putty will be absorbed within a period of 90 days.
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K Number
K091321Device Name
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY
Manufacturer
BACTERIN INTERNATIONAL INC.
Date Cleared
2009-09-11
(129 days)
Product Code
MQV, MBP
Regulation Number
888.3045Why did this record match?
Applicant Name (Manufacturer) :
BACTERIN INTERNATIONAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
OsteoSelect™ (DBM) Putty is indicated for use as a bone void filler and bone graft substitute for voids or gaps in the extremities and pelvis that are not intrinsic to the stability of bony structure. It is indicated for treatment of surgically created osseous defects or osseous defects from traumatic injury to the bone.
Device Description
OsteoSelect™ Demineralized Bone Matrix Putty is processed human bone that has been demineralized and combined with an absorbable carrier that is biocompatible and biodegradable. The combination of demineralized bone and the absorbable carrier results in a putty-like consistency for ease and flexibility of use during surgical application. The carrier material is a mixture of carboxymethylcellulose and phosphate buffered saline. OsteoSelect™ Putty is virtually odorless, tan in color and can be spread easily with minimal adhesion to surgical gloves.
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K Number
K063245Device Name
ELUTIA COATED CLOSED SURGICAL WOUND DRAIN
Manufacturer
BACTERIN INTERNATIONAL INC.
Date Cleared
2007-11-28
(398 days)
Product Code
OEI
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
BACTERIN INTERNATIONAL INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The subject device is intended for the evacuation of biological fluids from wounds or body cavities. Closed wound drainage systems have been used by various surgical specialties, including: orthopedic, general, reconstructive, neurological, gynecological, head and neck, thoracic / cardiovascular, and plastic surgery.
Device Description
The Elutia ™ Coated Closed Surgical Wound Drain is a radiopaque, single-use silicone wound drain with extension tubing for use with available drain reservoirs that include an anti-reflux valve. The drain is channeled for its entire length. It is available in round or flat configurations and in multiple sizes. A low profile connector joins the drain to clear silicone extension tubing. The drain is packaged sterile in a double pouch and is non-pyrogenic. The hydrogel coating containing silver sulfadiazine has been shown to reduce bacterial contamination on the surface of the wound drain by greater than 99.99% over a 7 day period as tested under USP <51> conditions against the following microorganisms: S. aureus, P. aeruginosa, E. coli, and C. albicans. The clinical significance of this finding is unknown. The subject device is composed of materials that have been successfully used in medical devices including the predicate devices. The subject device is composed of medical grade silicone (indwelling catheter, connector, and external tubing). The device is coated with silver sulfadiazine. USP grade silver sulfadiazine is used. The active drug substance is chemically synthesized and does not contain any animal or cell cultures derived from products or additives such as albumin or serum. The materials used in the subject device have been subjected to and passed biocompatibility testing. Additionally, the materials have been successfully used in other medical devices including the predicate devices. The subject devices are sterile single-use devices. Sterilization was performed.
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