| Primary Device ID | B167700430200 |
| NIH Device Record Key | 0c3bff4f-c209-4b04-83eb-b4ee4d09bd9e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | CURE ACP |
| Version Model Number | 700-430-20 |
| Company DUNS | 182698477 |
| Company Name | MEDITECH SPINE, LLC |
| 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 | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B167700430200 [Primary] |
| KWQ | Appliance, fixation, spinal intervertebral body |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B167700430200]
Moist Heat or Steam Sterilization
[B167700430200]
Moist Heat or Steam Sterilization
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2018-11-22 |
| Device Publish Date | 2017-10-10 |
| B167S1700435100 | S1-700-435-10 |
| B167S1700430200 | S1-700-430-20 |
| B167S1700430180 | S1-700-430-18 |
| B167S1700430160 | S1-700-430-16 |
| B167S1700430140 | S1-700-430-14 |
| B167S1700430120 | S1-700-430-12 |
| B167S1700430100 | S1-700-430-10 |
| B167900430600 | 900-430-60 |
| B167900430550 | 900-430-55 |
| B167900430500 | 900-430-50 |
| B167900430450 | 900-430-45 |
| B167900430400 | 900-430-40 |
| B167900430350 | 900-430-35 |
| B167900430300 | 900-430-30 |
| B167900430250 | 900-430-25 |
| B167900430200 | 900-430-20 |
| B167700455000 | 700-455-00 |
| B167700436000 | 700-436-00 |
| B167700435100 | 700-435-10 |
| B167700430200 | 700-430-20 |
| B167700430180 | 700-430-18 |
| B167700430160 | 700-430-16 |
| B167700430140 | 700-430-14 |
| B167700430120 | 700-430-12 |
| B167700430100 | 700-430-10 |