| Primary Device ID | 07290017626161 |
| NIH Device Record Key | 5b461d3b-0e89-45c0-a223-52a469bae101 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CyclaPlex Drill Bits 1.8-3.0 |
| Version Model Number | V7 |
| Catalog Number | DB-9243 |
| Company DUNS | 600372473 |
| Company Name | ALPHAMET LTD |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | false |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07290017626161 [Primary] |
| GS1 | 07290017626178 [Package] Package: Box [5 Units] In Commercial Distribution |
| GS1 | 07290017626864 [Package] Package: Packing box [20 Units] In Commercial Distribution |
| HTN | Washer, Bolt Nut |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[07290017626161]
Moist Heat or Steam Sterilization
[07290017626161]
Moist Heat or Steam Sterilization
[07290017626161]
Moist Heat or Steam Sterilization
[07290017626161]
Moist Heat or Steam Sterilization
| 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 | 2020-02-20 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 | 2020-02-20The 1.8 and 3.0 mm quick coupling drill bits are intended to be used for implantation of CyclaPlex Implant. |
| 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. |