FDA.reportPublic FDA data

Silktoe Spacer

Primary DI
08057717550894
Brand
Silktoe Spacer
Company
BRM EXTREMITIES SRL
Model
SIZE 50 RIGHT
Catalog number
BRDNEWP5050R
Published
2021-10-17
Public version status
Update
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
KWHProsthesis, Toe, Constrained, Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWHProsthesis, Toe, Constrained, PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057717550894PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057717550894080577175508948057717550894

GMDN Terms#

Term, Definition table
TermDefinition
Total metatarsophalangeal joint prosthesis, one-pieceAn implantable device designed to replace the metatarsophalangeal (MTP) joint(s) of the foot (toe). The device is made of a single piece of silicone elastomer. It is is intended to treat degenerative or traumatic arthritis, hallux valgus, hallus rigidus, and/or an unstable or painful MTP joint.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Special Storage Condition, Specify: Store 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08053782784608M3TOE SPACERBRM EXTREMITIES SRLKWH2026-10-19
08053782784615M3TOE SPACERBRM EXTREMITIES SRLKWH2026-10-19
08053782784622M3TOE SPACERBRM EXTREMITIES SRLKWH2026-10-19
08053782784639M3TOE SPACERBRM EXTREMITIES SRLKWH2026-10-19
08053782784646M3TOE SPACERBRM EXTREMITIES SRLKWH2026-10-19
08053782784653M3TOE SPACERBRM EXTREMITIES SRLKWH2026-10-19
00819034029181Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2023-07-14
00819034029198Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2023-07-14
00819034029211Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2023-07-14
00840124507456Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2023-07-14
00840124508989Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2023-07-14
00885556834244Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834268Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834282Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834305Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834329Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834374Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834398Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834411Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834435Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834534Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834558Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834572Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
00885556834596Silicone Toe SystemSmith & Nephew, Inc.KWH2022-12-22
08057717550801Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550818Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550825Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550832Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550849Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550856Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17