ACE-FISCHER ™STAINLESS STEEL 2 HOLE POST 101010370
GUDID 00887868010606
Biomet Orthopedics, LLC
External orthopaedic fixation system, single-use, non-sterile| Primary Device ID | 00887868010606 |
| NIH Device Record Key | 9f50dcaa-aae1-40a9-9cbd-610d44369b20 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACE-FISCHER ™STAINLESS STEEL 2 HOLE POST |
| Version Model Number | 1010-10-370 |
| Catalog Number | 101010370 |
| 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
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868010606 [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 |
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
[00887868010606]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2020-07-20 |
| Device Publish Date | 2020-07-10 |
Devices Manufactured by Biomet Orthopedics, LLC
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 |
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