| Primary Device ID | 00889024703445 |
| NIH Device Record Key | 35f60439-6c1c-447a-8b34-9307ac706445 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TM Ankle Burr Guard C Large |
| Version Model Number | SSI008467 |
| Catalog Number | SSI008467 |
| Company DUNS | 056038268 |
| Company Name | Zimmer, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| 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 |
| Phone | 1 (800) 343-9500 |
| customerservice@zimmerbiomet.com |
| Device Size Text, specify | 0 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00889024703445 [Primary] |
| HWE | Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00889024703445]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2025-12-26 |
| Device Publish Date | 2025-12-18 |
| 00889024693012 - Left 3 Deg Tib Cut Guide Assy | 2025-12-26 |
| 00889024693029 - Right 3 Deg Tib Cut Guide Assy | 2025-12-26 |
| 00889024703445 - TM Ankle Burr Guard C Large | 2025-12-26 |
| 00889024703445 - TM Ankle Burr Guard C Large | 2025-12-26 |
| 00889024703872 - Offset Box Osteotome | 2025-12-26 |
| 00889024704008 - LB Type 1 Taper Extraction Insert | 2025-12-26 |
| 00889024704015 - LZ 12/14 Taper Extraction Insert | 2025-12-26 |
| 00889024704022 - LB 12/14 Taper Extraction Insert | 2025-12-26 |
| 00889024704039 - Fitmore Extraction Adapter - M | 2025-12-26 |