Versa-FX® 00-1193-010-00
GUDID 00889024035898
Zimmer, Inc.
Orthopaedic prosthesis implantation instrument, reusable| Primary Device ID | 00889024035898 |
| NIH Device Record Key | d7a7419b-882d-4cb8-8cb4-f5d78129eaab |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Versa-FX® |
| Version Model Number | 1193-10 |
| Catalog Number | 00-1193-010-00 |
| Company DUNS | 056038268 |
| Company Name | Zimmer, 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
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com | |
| Phone | +1(800)348-2759 |
| zimmer.consumerrelations@zimmerbiomet.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024035898 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150818
FDA Product Code
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024035898]
Moist Heat or Steam Sterilization
[00889024035898]
Moist Heat or Steam Sterilization
[00889024035898]
Moist Heat or Steam Sterilization
[00889024035898]
Moist Heat or Steam Sterilization
[00889024035898]
Moist Heat or Steam Sterilization
[00889024035898]
Moist Heat or Steam Sterilization
[00889024035898]
Moist Heat or Steam Sterilization
[00889024035898]
Moist Heat or Steam Sterilization
[00889024035898]
Moist Heat or Steam Sterilization
[00889024035898]
Moist Heat or Steam Sterilization
[00889024035898]
Moist Heat or Steam Sterilization
[00889024035898]
Moist Heat or Steam Sterilization
[00889024035898]
Moist Heat or Steam Sterilization
[00889024035898]
Moist Heat or Steam Sterilization
[00889024035898]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2019-08-22 |
| Device Publish Date | 2016-07-27 |
On-Brand Devices [Versa-FX®]
Trademark Results [Versa-FX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VERSA-FX 74172622 1742228 Live/Registered |
ZIMMER, INC. 1991-05-31 |
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