Versa-Fx® 00-1198-090-11
GUDID 00889024037946
Zimmer, Inc.
Orthopaedic fixation plate, non-bioabsorbable, sterile| Primary Device ID | 00889024037946 |
| NIH Device Record Key | 506c1103-4edb-47ed-ad4f-3fd4718a85f0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Versa-Fx® |
| Version Model Number | 1198-90-11 |
| Catalog Number | 00-1198-090-11 |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| 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 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
| Angle | 90 degree |
| Length | 205 Millimeter |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024037946 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K150818
FDA Product Code
| JDI | Prosthesis, hip, semi-constrained, metal/polymer, cemented |
| JDP | condylar plate fixation Implant |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2019-08-12 |
| Device Publish Date | 2015-09-24 |
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 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.