| Primary Device ID | 10705034245621 |
| NIH Device Record Key | 45ad112b-d8c0-4f62-9a57-2112bc008565 |
| Commercial Distribution Discontinuation | 2019-07-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Version Model Number | SPB200 |
| Catalog Number | SPB200 |
| Company DUNS | 107105876 |
| Company Name | DEPUY SPINE, LLC |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | false |
| 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 |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10705034245621 [Primary] |
| JEB | TABLE, SURGICAL WITH ORTHOPEDIC ACCESSORIES, MANUAL |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 7 |
| Public Version Date | 2020-03-23 |
| Device Publish Date | 2016-12-31 |
| 10705034577111 - N/A | 2025-07-01 COBB, RIGHT 12.7mm |
| 10705034577128 - N/A | 2025-07-01 COBB, LEFT 12.7mm |
| 10705034577135 - N/A | 2025-07-01 COBB 12.7mm |
| 10705034577142 - N/A | 2025-07-01 COBB 20mm |
| 10705034577159 - N/A | 2025-07-01 COBB, RIGHT 20mm |
| 10705034577166 - N/A | 2025-07-01 COBB, LEFT 20mm |
| 10705034571102 - N/A | 2025-06-27 ROD HOLDER |
| 10705034577364 - N/A | 2025-06-27 THREADED REDUCER T-HANDLE, TALL |