| Primary Device ID | 10886982346896 | 
| NIH Device Record Key | aaecaccc-3585-4836-978e-b11c663b5813 | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | MAXFRAME | 
| Version Model Number | 03.312.003 | 
| Catalog Number | 03312003 | 
| Company DUNS | 486711679 | 
| Company Name | Synthes GmbH | 
| 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 | false | 
| 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 | 
| 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 Issuing Agency | Device ID | 
|---|---|
| GS1 | 10886982346896 [Primary] | 
| OSN | Software for diagnosis/treatment | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2024-12-17 | 
| Device Publish Date | 2024-12-09 | 
| 07612334107190 | MAXFRAME(TM) FOOT PL LONG 120MM/150MM/180MM/210MM | 
| 07612334107176 | MAXFRAME(TM) STRUT SWAP KIT CASE | 
| 07612334118554 | MAXFRAME(TM) SHOULDER BOLT RACK | 
| 07612334105448 | MAXFRAME(TM) IMPLANTS/INSTR CASE 3 | 
| 07612334107213 | MAXFRAME(TM) IMPLANTS/ STANDARD STRUTS | 
| 07612334107206 | MAXFRAME(TM) IMPLANTS/ QUICK ADJUST STRUTS | 
| 07612334107152 | MAXFRAME(TM) 5/8 & BRIDGING PL 150MM/180MM/210MM | 
| 07612334105431 | MAXFRAME(TM) FULL RINGS 150MM/180MM/210MM | 
| 07612334105240 | MAXFRAME (TM) FOOT PL SHORT 120MM, 150MM, 180MM, 210MM | 
| 07612334107220 | MAXFRAME (TM) RINGS 90MM & 120MM | 
| 07612334105424 | MAXFRAME(TM) IMPLANTS/INSTR CASE 2 | 
| 07612334105417 | MAXFRAME(TM) IMPLANTS/INSTR CASE 1 | 
| 07612334107237 | WIRE TENSIONER | 
| H679033128180 | MAXFRAME(TM) STANDARD STRUT/LONG | 
| H679033128170 | MAXFRAME(TM) STANDARD STRUT/MEDIUM | 
| H679033128160 | MAXFRAME(TM) STANDARD STRUT/SHORT | 
| H679033128150 | MAXFRAME(TM) STANDARD STRUT/X-SHORT | 
| H679033128140 | MAXFRAME(TM) STANDARD STRUT/XX-SHORT | 
| H679033128130 | MAXFRAME(TM) QUICK ADJUST STRUT/LONG | 
| H679033128120 | MAXFRAME(TM) QUICK ADJUST STRUT/MEDIUM | 
| H679033128110 | MAXFRAME(TM) QUICK ADJUST STRUT/SHORT | 
| H679033128100 | MAXFRAME(TM) QUICK ADJUST STRUT/X-SHORT | 
| H679033128300 | MAXFRAME(TM) SHOULDER BOLT FOR 8MM RINGS | 
| H679033128210 | MAXFRAME(TM) STRUT ID PLUG SET | 
| H679033128200 | MAXFRAME(TM) STRUT ID BAND SET | 
| H679033124400 | MAXFRAME(TM) BRIDGING PLATE FOR 5/8 RING 240MM/ALUMINUM | 
| H679033124100 | MAXFRAME(TM) BRIDGING PLATE FOR 5/8 RING 210MM/ALUMINUM | 
| H679033123800 | MAXFRAME(TM) BRIDGING PLATE FOR 5/8 RING 180MM/ALUMINUM | 
| H679033123500 | MAXFRAME(TM) BRIDGING PLATE FOR 5/8 RING 150MM/ALUMINUM | 
| H679033122700 | MAXFRAME(TM) FULL RING 270MM ALUMINUM | 
| H679033122400 | MAXFRAME(TM) FULL RING 240MM ALUMINUM | 
| H679033122100 | MAXFRAME(TM) FULL RING 210MM ALUMINUM | 
| H679033121800 | MAXFRAME(TM) FULL RING 180MM ALUMINUM | 
| H679033121500 | MAXFRAME(TM) FULL RING 150MM ALUMINUM | 
| H679033121200 | MAXFRAME(TM) FULL RING 120MM ALUMINUM | 
| H679033127400 | MAXFRAME(TM) 5/8 RING 240MM/ALUMINUM | 
| H679033127100 | MAXFRAME(TM) 5/8 RING 210MM/ALUMINUM | 
| H679033126800 | MAXFRAME(TM) 5/8 RING 180MM/ALUMINUM | 
| H679033126500 | MAXFRAME(TM) 5/8 RING 150MM/ALUMINUM | 
| H679033126200 | MAXFRAME(TM) 5/8 RING 120MM/ALUMINUM | 
| H679033125900 | MAXFRAME(TM) 5/8 RING 90MM/ALUMINUM | 
| H679033122010 | MAXFRAME(TM) FOOT PLATE SHORT 210MM/ALUMINUM | 
| H679033121810 | MAXFRAME(TM) FOOT PLATE SHORT 180MM/ALUMINUM | 
| H679033120900 | MAXFRAME(TM) FULL RING 90MM/ALUMINUM | 
| H679033121610 | MAXFRAME(TM) FOOT PLATE SHORT 150MM/ALUMINUM | 
| H679033121410 | MAXFRAME(TM) FOOT PLATE SHORT 120MM/ALUMINUM | 
| H679033123010 | MAXFRAME(TM) FOOT PLATE LONG 210MM/ALUMINUM | 
| H679033122810 | MAXFRAME(TM) FOOT PLATE LONG 180MM/ALUMINUM | 
| H679033122610 | MAXFRAME(TM) FOOT PLATE LONG 150MM/ALUMINUM | 
| H679033122410 | MAXFRAME(TM) FOOT PLATE LONG 120MM/ALUMINUM | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  MAXFRAME  86804597  5413295 Live/Registered | Depuy Synthes, Inc. 2015-10-30 |