Silktoe Spacer

Basic Information

• Brand Name: Silktoe Spacer
• Primary DI: 08057717550856
• Version / Model: SIZE 35 RIGHT
• Catalog Number: BRDNEWP3535R
• Company Name: BRM EXTREMITIES SRL
• Labeler DUNS: 435126746
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-17
• Public Version: 1
• Public Version Date: 2021-10-25
• Public Version Status: New
• Public Device Record Key: a9fc1e0c-639d-4e35-baba-fbdfe29016e5

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: Yes
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KWH	Prosthesis, Toe, Constrained, Polymer	Orthopedic	888.3720	2

GMDN Terms

Code	Name	Definition	Implantable	Status
33700	Total metatarsophalangeal joint prosthesis, one-piece	An 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.	Yes	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	08057717550856	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K191966	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			35 RIGHT

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Special Storage Condition, Specify: Store at room temperature, keep dry and away from humidity and direct sources of light and heat.