FDA.reportPublic FDA data

Bioplan Titanium implant

Primary DI
08053782783816
Brand
Bioplan Titanium implant
Company
BRM EXTREMITIES SRL
Model
Bioplan Titanium implant 13
Catalog number
DBI113019
Published
2026-08-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222820000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222820000BRM TOOL Screws, BIOPLAN Subtalar ImplantBrm Extremities2022-12-16HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08053782783816PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08053782783816080537827838168053782783816

GMDN Terms#

Term, Definition table
TermDefinition
Subtalar implant, non-bioabsorbableA device designed to be implanted into the calcaneus bone or sinus tarsi of the foot to stabilize the subtalar/talotarsal joint to treat a hyperpronated foot (inward rotation during gait) and sequelae (e.g., flat foot) or other heel/arch abnormalities; it is not intended for arthrodesis/joint fusion. It is a non-bioabsorbable device typically made of a metal (e.g., titanium alloy) or polyethylene (PE).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature, keep dry and away from humidity and direct sources of light and heat

Contacts#

Phone, Email table
PhoneEmail
+3903411693087info@brm-extremities.com

Regulatory Flags#

DUNS number
435126746
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08053782783830TITANIUM SCREWØ 2.2 x 12M3ST22012PS2026-10-19
08053782783847TITANIUM SCREWØ 2.2 x 14M3ST22014PS2026-10-19
08053782783915TITANIUM SCREWØ 2.2 x 28M3ST22028PS2026-10-19
08053782783922TITANIUM SCREWØ 2.2 x 30M3ST22030PS2026-10-19
08053782783939TITANIUM SCREWØ 2.2 x 32M3ST22032PS2026-10-19
08053782783946TITANIUM SCREWØ 2.2 x 34M3ST22034PS2026-10-19
08053782783953TITANIUM SCREWØ 2.2 x 36M3ST22036PS2026-10-19
08053782783960TITANIUM SCREWØ 2.2 x 38M3ST22038PS2026-10-19
08053782783977TITANIUM SCREWØ 2.2 x 40M3ST22040PS2026-10-19
08053782784134TITANIUM SCREWØ 4.0 x 40M3SO40040PS2026-10-19
08053782784141TITANIUM SCREWØ 4.0 x 42M3SO40042PS2026-10-19
08053782784158TITANIUM SCREWØ 4.0 x 44M3SO40044PS2026-10-19
08053782784165TITANIUM SCREWØ 4.0 x 46M3SO40046PS2026-10-19
08053782784172TITANIUM SCREWØ 4.0 x 48M3SO40048PS2026-10-19
08053782784189TITANIUM SCREWØ 4.0 x 50M3SO40050PS2026-10-19
08053782784264CHAMFERED SCREWØ 2.5 x 20M3SS25020S2026-10-19
08053782784271CHAMFERED SCREWØ 2.5 x 22M3SS25022S2026-10-19
08053782784288CHAMFERED SCREWØ 2.5 x 24M3SS25024S2026-10-19
08053782784295CHAMFERED SCREWØ 2.5 x 26M3SS25026S2026-10-19
08053782784301CHAMFERED SCREWØ 2.5 x 28M3SS25028S2026-10-19

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Primary DI, Brand, Company table
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