FDA.reportPublic FDA data

Silktoe Spacer

Primary DI
08057717550801
Brand
Silktoe Spacer
Company
BRM EXTREMITIES SRL
Model
SIZE 20 LEFT
Catalog number
BRDNEWP2020L
Published
2021-10-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191966000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191966000NewPrim SystemBrm Extremities2020-02-13KWH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08057717550801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08057717550801080577175508018057717550801

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.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
435126746
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08053782783724BRM TOOL VIP SCREWS INSTRUMENTCannulated extra-long Drill Bit Ø 2.0 mmSTVI224XXLP2026-04-29
08053782783656BRM INSTRUMENTQuick Coupling Silicone HandleUAOI0SA00S2026-03-24
08053782783663BRM INSTRUMENTQuick Coupling Silicone Handle PROUAOI0SA00L2026-03-24
08053782783670BRM INSTRUMENTJ-Type Quick Coupling Silicone HandleUAOI0SJ0002026-03-24
08053782783687BRM INSTRUMENTQuick Coupling Silicone Handle with ratchetUAOI0SAC0S2026-03-24
08053782783694BRM INSTRUMENTQuick Coupling Silicone Handle PRO with ratchetUAOI0SAC0L2026-03-24
08053782783700BRM INSTRUMENTJ-Type Quick Coupling Silicone Handle with ratchetUAOI0SJC002026-03-24
08053782783748TOOL VIP XL Instruments KitInstruments kit for the implant of BRM ExtremitiesKIT.TOOLVIP-012026-03-24
08053782783731BRM TOOL VIP SCREWS INSTRUMENTCannulated extra-long Drill Bit Ø 2.9mmSTVI234XXLP2026-02-19
08053782781720BRM TOOL PRO Instruments KitInstruments KitKIT.TOOLPRO-002025-07-15
08053782780082BRM TOOL PRO SCREWS INSTRUMENTLong cannulated Screwdriver BTX20STAI100020L2025-10-15
08053782780099BRM TOOL PRO SCREWS INSTRUMENTLong solid Screwdriver BTX20STAI100020PL2025-10-15
08053782780105BRM TOOL SCREWS INSTRUMENTLong cannulated Screwdriver BTX25STOI100025L2025-10-15
08053782780112BRM TOOL SCREWS INSTRUMENTLong solid Screwdriver BTX25STOI100025PL2025-10-15
08053782780372BRM INSTRUMENTJ-Type Quick Coupling HandleUAOI0MJ1002025-10-15
08053782780389BRM TOOL PRO SCREWS INSTRUMENTMetallic sterilization tray for instruments – TOOLSTOI056070BPL2025-10-15
08053782780396BRM TOOL PRO SCREWS INSTRUMENTGuidewire Ø 1.6STAIGW0162025-10-15
08053782780402BRM TOOL PRO SCREWS INSTRUMENTGuidedrill Ø 3.9STAIGD0392025-10-15
08053782780419BRM TOOL PRO SCREWS INSTRUMENTTissue protection Sleeve Ø 5.6STAIPS0562025-10-15
08053782780426BRM TOOL PRO SCREWS INSTRUMENTGuidewire Ø 2.5STAIGW0252025-10-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
08057717550863Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550870Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550887Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
08057717550894Silktoe SpacerBRM EXTREMITIES SRLKWH2021-10-17
00840124506138Sgarlato SilasticFUSION ORTHOPEDICS, LLCKWH2021-08-18
00840124506145Sgarlato Silastic FUSION ORTHOPEDICS, LLCKWH2021-08-18
00840124506152Sgarlato Silastic FUSION ORTHOPEDICS, LLCKWH2021-08-18