Mergence™-S
GUDID 00889024316676
ZIMMER TRABECULAR METAL TECHNOLOGY INC.
Spinal implant trial| Primary Device ID | 00889024316676 |
| NIH Device Record Key | 4b31cea3-3b43-4c07-aea8-603521a1fd3f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Mergence™-S |
| Version Model Number | 96-101-06111 |
| Company DUNS | 793120965 |
| Company Name | ZIMMER TRABECULAR METAL TECHNOLOGY 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 | 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 |
Customer Support Contacts
Device Dimensions
| Device Size Text, specify | 0 |
| Height | 11 Millimeter |
| Device Size Text, specify | 0 |
| Height | 11 Millimeter |
| Device Size Text, specify | 0 |
| Height | 11 Millimeter |
| Device Size Text, specify | 0 |
| Height | 11 Millimeter |
| Device Size Text, specify | 0 |
| Height | 11 Millimeter |
| Device Size Text, specify | 0 |
| Height | 11 Millimeter |
| Device Size Text, specify | 0 |
| Height | 11 Millimeter |
| Device Size Text, specify | 0 |
| Height | 11 Millimeter |
| Device Size Text, specify | 0 |
| Height | 11 Millimeter |
| Device Size Text, specify | 0 |
| Height | 11 Millimeter |
| Device Size Text, specify | 0 |
| Height | 11 Millimeter |
| Device Size Text, specify | 0 |
| Height | 11 Millimeter |
| Device Size Text, specify | 0 |
| Height | 11 Millimeter |
| Device Size Text, specify | 0 |
| Height | 11 Millimeter |
| Device Size Text, specify | 0 |
| Height | 11 Millimeter |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024316676 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K133784
FDA Product Code
| ODP | Intervertebral fusion device with bone graft, cervical |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024316676]
Moist Heat or Steam Sterilization
[00889024316676]
Moist Heat or Steam Sterilization
[00889024316676]
Moist Heat or Steam Sterilization
[00889024316676]
Moist Heat or Steam Sterilization
[00889024316676]
Moist Heat or Steam Sterilization
[00889024316676]
Moist Heat or Steam Sterilization
[00889024316676]
Moist Heat or Steam Sterilization
[00889024316676]
Moist Heat or Steam Sterilization
[00889024316676]
Moist Heat or Steam Sterilization
[00889024316676]
Moist Heat or Steam Sterilization
[00889024316676]
Moist Heat or Steam Sterilization
[00889024316676]
Moist Heat or Steam Sterilization
[00889024316676]
Moist Heat or Steam Sterilization
[00889024316676]
Moist Heat or Steam Sterilization
[00889024316676]
Moist Heat or Steam Sterilization
[00889024316676]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-02-07 |
| Device Publish Date | 2017-09-20 |
On-Brand Devices [Mergence™-S]
Trademark Results [Mergence]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MERGENCE 77052371 3606453 Live/Registered |
Zimmer Biomet Spine, Inc. 2006-11-28 |
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