InCompass® 2101-12
GUDID 00889024401969
ZIMMER SPINE, INC.
Bone-screw internal spinal fixation system, non-sterile| Primary Device ID | 00889024401969 |
| NIH Device Record Key | 4ff0ce9d-3c7e-462d-976f-594b20bae369 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | InCompass® |
| Version Model Number | 2101-12 |
| Catalog Number | 2101-12 |
| Company DUNS | 787663400 |
| Company Name | ZIMMER SPINE, INC. |
| 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 | 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 |
Customer Support Contacts
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024401969 [Primary] |
FDA Product Code
| MNI | ORTHOSIS, SPINAL PEDICLE FIXATION |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
[00889024401969]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-12-03 |
| Device Publish Date | 2015-10-16 |
On-Brand Devices [InCompass®]
Trademark Results [InCompass]
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.