Duns Number:536935331
Device Description: In case of severe deformities of the forefoot, the basal osteotomy may be preferable to th In case of severe deformities of the forefoot, the basal osteotomy may be preferable to the distal osteotomy as it promotes a greater degree of correction. Due to the leverage effect, the osteotomy site is subject to significant dorsiflexion stress. The B-BOP plate is specifically designed for basal osteotomy of the first metatarsal, with strong stability. The set includes the B-BOP plates, screws, and instruments, including K-wire.
Catalog Number
BBOPSET
Brand Name
B-BOP
Version/Model Number
BBOPSET
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"
Yes
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
K022599,K052152
Product Code
HRS
Product Code Name
PLATE, FIXATION, BONE
Public Device Record Key
1f6825dd-f4bf-4ae5-a07e-3a8972b59baa
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
October 09, 2017
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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 388 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 235 |