TEMPFIX®CROSSBAR ASSEMBLY 808115000
GUDID 00887868034640
Biomet Orthopedics, LLC
External orthopaedic fixation system, single-use, sterile| Primary Device ID | 00887868034640 |
| NIH Device Record Key | 179e0e1c-8dc0-4e91-be11-c4c7f0bdbdd0 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TEMPFIX®CROSSBAR ASSEMBLY |
| Version Model Number | 8081-15-000 |
| Catalog Number | 808115000 |
| 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 | 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
| Phone | +1(800)348-9500 |
| customerservice@zimmerbiomet.com |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00887868034640 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K043113
FDA Product Code
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT |
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 | 2018-07-06 |
| Device Publish Date | 2015-10-24 |
Devices Manufactured by Biomet Orthopedics, LLC
| 00887868578250 - Comprehensive® | 2024-11-13 |
| 08428898885684 - BIPASS DISPOSABLE PUSHER | 2024-09-11 |
| 08428898885691 - BIPASS DISPOSABLE PUSHER | 2024-09-11 |
| 00880304338548 - AGC ANTERIOR FILE | 2024-09-11 |
| 00880304339224 - PARALLEL PULLER | 2024-09-11 |
| 00880304342187 - AGC MODULAR TIBIAL II | 2024-09-11 |
| 00880304365247 - BIO-MODULAR | 2024-09-11 |
| 00880304368637 - BOHN MODULAR FEMORAL STEM EXTRACTOR | 2024-09-11 |
Trademark Results [TEMPFIX]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TEMPFIX 78624746 3085280 Live/Registered |
BIOMET C.V. 2005-05-06 |
 TEMPFIX 78080215 not registered Dead/Abandoned |
DePuy, Inc. 2001-08-20 |
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