| Primary Device ID | 07290017626826 |
| NIH Device Record Key | 2bbf34b1-e907-4952-8890-d85c474e3746 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CyclaPlex Implant |
| Version Model Number | V7 |
| Catalog Number | IM-9101 |
| Company DUNS | 600372473 |
| Company Name | ALPHAMET LTD |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | true |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | (260) 438-2198 |
| bcoburn@genorthopartners.com | |
| Phone | (260) 438-2198 |
| bcoburn@genorthopartners.com | |
| Phone | (260) 438-2198 |
| bcoburn@genorthopartners.com | |
| Phone | (260) 438-2198 |
| bcoburn@genorthopartners.com | |
| Phone | (260) 438-2198 |
| bcoburn@genorthopartners.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290017626017 [Primary] |
| GS1 | 07290017626819 [Package] Contains: 07290017626017 Package: Packaging Box [20 Units] In Commercial Distribution |
| GS1 | 07290017626826 [Package] Contains: 07290017626819 Package: Shipping Box [4 Units] In Commercial Distribution |
| GS1 | 07290017626833 [Package] Contains: 07290017626819 Package: Shipping box [1 Units] In Commercial Distribution |
| HTN | Washer, Bolt Nut |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-02-20 |
| Device Publish Date | 2020-02-12 |
| 07290017626826 - CyclaPlex Implant | 2020-02-20The 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. |
| 07290017626826 - CyclaPlex Implant | 2020-02-20 The implant is comprised of two metallic bone screws ("Anchor1", "Anchor 2") connected by an UHMW polyethylene multiple suture c |
| 07290017626116 - CyclaPlex Correction System Instruments Case | 2020-02-20 The anodized aluminum Instruments Case is intended to accommodate the CyclaPlex surgery instruments in the right position for st |
| 07290017626123 - CyclaPlex Correction System Instruments Case Set | 2020-02-20 The CyclaPlex Correction System Instruments Case Set is comprised of the following instruments delivered together. Instruments C |
| 07290017626161 - CyclaPlex Drill Bits 1.8-3.0 | 2020-02-20 The 1.8 and 3.0 mm quick coupling drill bits are intended to be used for implantation of CyclaPlex Implant. |
| 07290017626192 - CyclaPlex Drill Guide | 2020-02-20 The CyclaPlex Drill Guide is a “H arm” device intended to guide drill bits at the right points and required drilling angles |
| 07290017626222 - CyclaPlex Screwdriver | 2020-02-20 The Screwdriver is intended to assist in threading the implant into the bone. |