MAXFRAME 03313151
GUDID 10886982306104
MAXFRAME(TM) HALF RING 150MM/ALUMINUM
SYNTHES (U.S.A.) LP
External orthopaedic fixation system, single-use, non-sterile| Primary Device ID | 10886982306104 |
| NIH Device Record Key | 5325f2fb-4b6f-4ff9-b092-36cef8e12117 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | MAXFRAME |
| Version Model Number | 03.313.151 |
| Catalog Number | 03313151 |
| Company DUNS | 832637081 |
| Company Name | SYNTHES (U.S.A.) LP |
| 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 | 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)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
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| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx | |
| Phone | +1(800)255-2500 |
| xx@xx.xx |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10886982306104 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K051600
FDA Product Code
| KTT | APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
[10886982306104]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-07-28 |
| Device Publish Date | 2021-07-20 |
On-Brand Devices [MAXFRAME]
| 07612334140258 | MAXFRAME(TM) SOFTWARE |
| H679033120100 | MAXFRAME(TM)FOOT PLATE SUPPORT KIT |
| 07612334224699 | MAXFRAME CONNECTING ELEMENT 3 |
| 07612334224682 | MAXFRAME CONNECTING ELEMENT 2 |
| 07612334224644 | MAXFRAME(TM)IMPLANTS/POLYAXIAL STRUTS WITH FINE /GROSS ADJUS |
| 07612334224637 | MAXFRAME(TM) BOLT RACK FOR LINEAR STRUT BOLT |
| 07612334224613 | MAXFRAME(TM)CONNECTING ELEMENT |
| 10886982306487 | MAXFRAME(TM) RETENTION BAND |
| 07612334224583 | MAXFRAME(TM) IMPLANTS/ LINEAR STRUTS & HARDWARE |
| 07612334224590 | MAXFRAME(TM)IMPLANTS/POLYAXIAL STRUTS WITH GROSS ADJUSTMENT |
| 10886982306456 | MAXFRAME(TM) SLOTTED WASHER |
| 10886982306449 | MAXFRAME(TM) TABBED WASHER |
| 10886982306432 | MAXFRAME(TM) WIRE BOLT SHORT SLOTTED |
| 10886982306425 | MAXFRAME(TM) LINEAR STRUT BOLT |
| 10886982306418 | MAXFRAME(TM) RIGHT ANGLE POST |
| 10886982306401 | MAXFRAME(TM) RING MOUNT FOR 5-6MM |
| 10886982306395 | MAXFRAME(TM) RING MOUNT FOR 4-5MM |
| 10886982306388 | MAXFRAME(TM) MULTI PARALLEL PIN MOUNT POST 6 HIGH |
| 10886982306371 | MAXFRAME(TM) MULTI PARALLEL PIN MOUNT POST 5 HIGH |
| 10886982306364 | MAXFRAME(TM) MULTI PARALLEL PIN MOUNT POST 4 HIGH |
| 10886982306357 | MAXFRAME(TM) MULTI PARALLEL PIN MOUNT POST 3 HIGH |
| 10886982306340 | MAXFRAME(TM) MULTI PARALLEL PIN MOUNT POST 2 HIGH |
| 10886982306333 | MAXFRAME(TM) MULTI PARALLEL PIN MOUNT POST 1 HIGH |
| 10886982306326 | MAXFRAME(TM) STANDOFF 100MM |
| 10886982306319 | MAXFRAME(TM) STANDOFF 80MM |
| 10886982306302 | MAXFRAME(TM) STANDOFF 65MM |
| 10886982306296 | MAXFRAME(TM) MULTI PARALLEL PIN MOUNT BOLT |
| 10886982306289 | MAXFRAME(TM) POLYAXIAL STRUT FINE AND GROSS ADJUST/LONG |
| 10886982306272 | MAXFRAME(TM) POLYAXIAL STRUT FINE AND GROSS ADJUST/MEDIUM |
| 10886982306265 | MAXFRAME(TM) POLYAXIAL STRUT FINE AND GROSS ADJUST/SHORT |
| 10886982306258 | MAXFRAME(TM) POLYAXIAL STRUT FINE AND GROSS ADJUST/X-SHORT |
| 10886982306241 | MAXFRAME(TM) POLYAXIAL STRUT GROSS ADJUST/LONG |
| 10886982306234 | MAXFRAME(TM) POLYAXIAL STRUT GROSS ADJUST/MEDIUM |
| 10886982306227 | MAXFRAME(TM) POLYAXIAL STRUT GROSS ADJUST/SHORT |
| 10886982306210 | MAXFRAME(TM) POLYAXIAL STRUT GROSS ADJUST/X-SHORT |
| 10886982306203 | MAXFRAME(TM) POLYAXIAL STRUT GROSS ADJUST/XX-SHORT |
| 10886982306197 | MAXFRAME(TM) LINEAR STRUT/LONG |
| 10886982306180 | MAXFRAME(TM) LINEAR STRUT/MEDIUM |
| 10886982306173 | MAXFRAME(TM) LINEAR STRUT/SHORT |
| 10886982306166 | MAXFRAME(TM) THIRD RING 210MM/ALUMINUM |
| 10886982306159 | MAXFRAME(TM) THIRD RING 180MM/ALUMINUM |
| 10886982306142 | MAXFRAME(TM) THIRD RING 150MM/ALUMINUM |
| 10886982306135 | MAXFRAME(TM) THIRD RING 120MM/ALUMINUM |
| 10886982306128 | MAXFRAME(TM) HALF RING 210MM/ALUMINUM |
| 10886982306111 | MAXFRAME(TM) HALF RING 180MM/ALUMINUM |
| 10886982306104 | MAXFRAME(TM) HALF RING 150MM/ALUMINUM |
| 10886982306098 | MAXFRAME(TM) HALF RING 120MM/ALUMINUM |
| 07612334226563 | MAXFRAME(TM) 2.0 SOFTWARE |
| 07612334224606 | MAXFRAME(TM) SCHANZ SCREW INSTRUMENTS AND DRILL BITS |
| 07612334224620 | MAXFRAME(TM)HALF & THIRD RINGS 120MM/ 150MM/ 180 MM/210MM |
Trademark Results [MAXFRAME]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 MAXFRAME 86804597 5413295 Live/Registered |
Depuy Synthes, Inc. 2015-10-30 |
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