OsseoFit™ Stemless Shoulder 00-5380-000-14
GUDID 00889024678774
Zimmer, Inc.
Coated shoulder humeral stem prosthesis| Primary Device ID | 00889024678774 |
| NIH Device Record Key | 4f41f66a-38d1-4ae4-9d0b-138a52944c84 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OsseoFit™ Stemless Shoulder |
| Version Model Number | 00-5380-000-14 |
| Catalog Number | 00-5380-000-14 |
| Company DUNS | 056038268 |
| Company Name | Zimmer, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | MR Conditional |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| 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 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024678774 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K241873
FDA Product Code
| PKC | Prosthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-12-26 |
| Device Publish Date | 2024-12-18 |
On-Brand Devices [OsseoFit™ Stemless Shoulder]
Trademark Results [OsseoFit]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OSSEOFIT 97924878 not registered Live/Pending |
Zimmer, Inc. 2023-05-08 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.