Identity
- Trade Name
- CyclaPlex Implant FDA UDI
- Generic Name
- Orthopaedic bone screw, non-bioabsorbable, sterile FDA UDI
- Device Name
- The implant is comprised of two metallic bone screws ("Anchor1", "Anchor 2") connected by an UHMW polyethylene multiple suture cord. The implant device pulls the 1st metatarsal inward, towards the 2nd metatarsal and reduces the intermetatarsal angle to normal medically-accepted values. It is intended to assist in the correction of Hallux Valgus deformities by providing reduction of the first intermetatarsal angle. FDA UDI
- Model / Reference
- V7 FDA UDI
- Description
- The implant is comprised of two metallic bone screws ("Anchor1", "Anchor 2") connected by an UHMW polyethylene multiple suture cord. The implant device pulls the 1st metatarsal inward, towards the 2nd metatarsal and reduces the intermetatarsal angle to normal medically-accepted values. It is intended to assist in the correction of Hallux Valgus deformities by providing reduction of the first intermetatarsal angle. FDA UDI
Identifiers
- Catalog Number
- IM-9101 FDA UDI
- Primary DI / UDI-DI
- 07290017626017 FDA UDI
- 510(k) Number
- K183094 FDA UDI
- FDA Product Code
- HTN FDA UDI
- GMDN Term
- Orthopaedic bone screw, non-bioabsorbable, sterile 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Conditional FDA UDI
Category: Orthopaedic bone screw, non-bioabsorbable, sterile
CyclaPlex Implant by Alphamet Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthopaedic bone screw, non-bioabsorbable, sterile.
- EPS Plating System Screw — GRAMERCY EXTREMITY ORTHOPEDICS, LLC. · Class II
- A.L.P.S.CORTICAL SCREW — Biomet Orthopedics, Inc. · Class II
- Peri-Loc — Smith & Nephew, Inc. · Class II
- Cortical Screw 2.5mm x 24mm Sterile — BIOPRO, INC. · Class II
- OsteoMed — Osteomed Corp. · Class II
- 3.5mm x 10mm Ti Cortical Screw — WISHBONE MEDICAL INC. · Class II
- primaLOK FF — Wenzel Spine · U
- MAX VPC™VARIABLE PITCH COMPRESSION SCREW — Biomet Orthopedics, Inc. · Class II
Cleared under the same submission
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
- Alphamet Ltd
Sources (1)
- FDA UDI 2bbf34b1-e907-4952-8890-d85c474e3746 36 fields · synced May 31, 2026