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510(k) Data Aggregation
K Number
K220142Device Name
BRM Digitalis Spacer
Manufacturer
BRM Extremities Srl
Date Cleared
2023-04-04
(441 days)
Product Code
KYJ
Regulation Number
888.3230Why did this record match?
Applicant Name (Manufacturer) :
BRM Extremities Srl
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Digitalis Spacer MCP implants are intended for replacement of the metacarpophalangeal joint of the hand which has been damaged by:
- Osteoarthrosis;
- Rheumatoid arthritis;
- Post traumatic arthritis.
The Digitalis Spacer PIP implants are intended for replacement of the proximal interphalangeal joint of the hand which has been damaged by:
- Rheumatoid arthritis;
- Osteoarthritis;
- Ankylosed joints or those with limited range of motion which have not responded to conservative treatment;
- Non-functional joint due to inadequate bony alignment and joint space which cannot be restored by soft tissue reconstruction alone;
- Destroyed articular surface(s).
Device Description
The Digitalis Spacer is a double-stemmed, constrained, silicone prosthesis with a hinge joint. The subject device is available in two options, one intended for use in the metacarpophalangeal (MCP) and the other for use in the proximal interphalangeal joints (PIP). The implant MCP option is intended to be implanted to replace the osteo-cartilaginous heads of the metacarpophalangeal joint an act as a joint spacer between the resected head of the metacarpal at the distal head and the base of the proximal phalanx. The implant PIP option is intended to be implanted to replace the osteo-cartilaginous heads of the proximal interphalangeal joint and act as a joint spacer between the head of proximal phalanx and base of the medial phalanx.
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K Number
K203773Device Name
BRM TOOL Screws
Manufacturer
BRM Extremities Srl
Date Cleared
2022-01-14
(387 days)
Product Code
HWC
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
BRM Extremities Srl
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The BRM TOOL Screws are indicated for use for aligned bone fracture repair and arthrodesis, osteotomy, joint fusion and bone fragment fixation appropriate with the size of the screw.
Device Description
The BRM TOOL Screws are interfragmentary compression osteosynthesis screws, i.e., devices used in surgical orthopedic interventions to provide support to the bone, ligament, tendon or cartilage structure, with the aim to reduce fractures in several parts of the skeleton, particularly of bone epiphyses. The application field excludes spinal, rib cage and skull bones. The BRM TOOL Screws are available in Titanium alloy.
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