ACE-FISCHER ™STAINLESS STEEL THREADED ROD 101273010
GUDID 00887868010682
Biomet Orthopedics, LLC
External orthopaedic fixation system, single-use, non-sterile External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use External orthopaedic fixation system, single-use| Primary Device ID | 00887868010682 |
| NIH Device Record Key | dda76137-1be1-406b-a719-2ff0ffdd1ec6 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACE-FISCHER ™STAINLESS STEEL THREADED ROD |
| Version Model Number | 1012-73-010 |
| Catalog Number | 101273010 |
| Company DUNS | 129278169 |
| Company Name | Biomet Orthopedics, LLC |
| 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
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com | |
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com |
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 Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868010682 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K083789
FDA Product Code
| JDW | PIN, FIXATION, THREADED |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00887868010682]
Moist Heat or Steam Sterilization
[00887868010682]
Moist Heat or Steam Sterilization
[00887868010682]
Moist Heat or Steam Sterilization
[00887868010682]
Moist Heat or Steam Sterilization
[00887868010682]
Moist Heat or Steam Sterilization
[00887868010682]
Moist Heat or Steam Sterilization
[00887868010682]
Moist Heat or Steam Sterilization
[00887868010682]
Moist Heat or Steam Sterilization
[00887868010682]
Moist Heat or Steam Sterilization
[00887868010682]
Moist Heat or Steam Sterilization
[00887868010682]
Moist Heat or Steam Sterilization
[00887868010682]
Moist Heat or Steam Sterilization
[00887868010682]
Moist Heat or Steam Sterilization
[00887868010682]
Moist Heat or Steam Sterilization
[00887868010682]
Moist Heat or Steam Sterilization
[00887868010682]
Moist Heat or Steam Sterilization
[00887868010682]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2015-10-24 |
On-Brand Devices [ACE-FISCHER ™STAINLESS STEEL THREADED ROD]
| 00887868010743 | 1012-73-040 |
| 00887868010736 | 1012-73-035 |
| 00887868010729 | 1012-73-030 |
| 00887868010712 | 1012-73-025 |
| 00887868010705 | 1012-73-020 |
| 00887868010699 | 1012-73-015 |
| 00887868010682 | 1012-73-010 |
Trademark Results [ACE-FISCHER]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACE-FISCHER 73421065 1281428 Live/Registered |
Ace Orthopedic Company, Inc. 1983-04-11 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.