Duns Number:081067703
Device Description: OptiFuse BA is a bone void filler consisting of a collagen matrix mineralized with hydroxy OptiFuse BA is a bone void filler consisting of a collagen matrix mineralized with hydroxyapatite (HA) – tri-calcium phosphate (TCP) granules and 45S5 bioactive glass granules. The bovine fibrillar collagen component is biocompatible and the 45S5 glass particles are bioactive.OptiFuse BA is indicated for use in bony voids or gaps of the skeletal system (i.e. extremities, pelvis and posterolateral spine). These osseous defects are surgically created or result from traumatic injury to the bone and are not intrinsic to the stability of the bony structure. The graft resorbs and is replaced by the growth of new bone during the healing process. OptiFuse BA must be used with autogenous bone marrow aspirate and autograft in the posterolateral spine.
Catalog Number
7888-0063
Brand Name
OptiFuse BA 6.25cc Strip
Version/Model Number
7888-0063
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K170917
Product Code
MQV
Product Code Name
Filler, Bone Void, Calcium Compound
Public Device Record Key
7a067a44-f12c-4a78-8b9e-66bef1c7c2c6
Public Version Date
June 19, 2020
Public Version Number
4
DI Record Publish Date
January 09, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 178 |