Identity
- Trade Name
- Geminus FDA UDI
- Generic Name
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
- Model / Reference
- GEMINUS Volar Distal Radius Plate, Wide, 4 Hole, Right FDA UDI
Identifiers
- Catalog Number
- GMN-RTW-4HL FDA UDI
- Primary DI / UDI-DI
- 00841506101675 FDA UDI
- 510(k) Number
- K111620 FDA UDI
- FDA Product Code
- HRS FDA UDI
- GMDN Term
- Orthopaedic fixation plate, non-bioabsorbable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 888.3030 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Orthopaedic fixation plate, non-bioabsorbable
Geminus by Skeletal Dynamics L.l.c. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic fixation plate, non-bioabsorbable.
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- Traufix osteosynthesis, osteotomy, and arthrodesis devices — Fixier S.A. DE C.V. · Class II
- PŁYTKI DO TWARZOCZASZKI — ChM spółka z ograniczoną odpowiedzialnością · Class IIb
- AXSOS — Stryker Corp. · Class II
- Xpert Wrist — NEWCLIP TECHNICS · Class II
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- ORTHOLOC 3DSi CLAW II — WRIGHT MEDICAL TECHNOLOGY, INC. · Class II
Cleared under the same submission
K111620 also covers:
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
- Geminus — SKELETAL DYNAMICS L.L.C.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Skeletal Dynamics L.l.c.
Sources (1)
- FDA UDI 90f3e5bd-0700-4819-b94a-0e26c9a20aef 35 fields · synced May 31, 2026