The following data is part of a premarket notification filed by Spinecraft Llc with the FDA for Altum Anterior Cervical Plate.
| Device ID | K103505 |
| 510k Number | K103505 |
| Device Name: | ALTUM ANTERIOR CERVICAL PLATE |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | SPINECRAFT LLC 2215 ENTERPRISE DRIVE SUITE 1504 Westchester, IL 60154 |
| Contact | Ami Akallal-asaad |
| Correspondent | Ami Akallal-asaad SPINECRAFT LLC 2215 ENTERPRISE DRIVE SUITE 1504 Westchester, IL 60154 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-29 |
| Decision Date | 2011-03-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M824VS145181 | K103505 | 000 |
| M824FS140121 | K103505 | 000 |
| M824ACH14961 | K103505 | 000 |
| M824ACH14921 | K103505 | 000 |
| M824ACH14881 | K103505 | 000 |
| M824ACH14841 | K103505 | 000 |
| M824ACH14801 | K103505 | 000 |
| M824ACH14761 | K103505 | 000 |
| M824ACH14721 | K103505 | 000 |
| M824ACH14681 | K103505 | 000 |
| M824ACH14641 | K103505 | 000 |
| M824ACH14601 | K103505 | 000 |
| M824ACH13691 | K103505 | 000 |
| M824FS140141 | K103505 | 000 |
| M824FS140161 | K103505 | 000 |
| M824VS145161 | K103505 | 000 |
| M824VS145141 | K103505 | 000 |
| M824VS145121 | K103505 | 000 |
| M824VS140181 | K103505 | 000 |
| M824VS140161 | K103505 | 000 |
| M824VS140141 | K103505 | 000 |
| M824VS140121 | K103505 | 000 |
| M824FS145181 | K103505 | 000 |
| M824FS145161 | K103505 | 000 |
| M824FS145141 | K103505 | 000 |
| M824FS145121 | K103505 | 000 |
| M824FS140181 | K103505 | 000 |
| M824ACH13661 | K103505 | 000 |
| M824ACH13631 | K103505 | 000 |
| M824ACH12301 | K103505 | 000 |
| M824ACH12281 | K103505 | 000 |
| M824ACH12261 | K103505 | 000 |
| M824ACH11261 | K103505 | 000 |
| M824ACH11241 | K103505 | 000 |
| M824ACH11221 | K103505 | 000 |
| M824ACH11201 | K103505 | 000 |
| M824ACH11181 | K103505 | 000 |
| M824ACH11161 | K103505 | 000 |
| M824ACH11141 | K103505 | 000 |
| M824ACH11121 | K103505 | 000 |
| M824ACH11101 | K103505 | 000 |
| M824ACH12321 | K103505 | 000 |
| M824ACH12341 | K103505 | 000 |
| M824ACH13601 | K103505 | 000 |
| M824ACH13571 | K103505 | 000 |
| M824ACH13541 | K103505 | 000 |
| M824ACH13511 | K103505 | 000 |
| M824ACH13481 | K103505 | 000 |
| M824ACH13451 | K103505 | 000 |
| M824ACH12461 | K103505 | 000 |
| M824ACH12441 | K103505 | 000 |
| M824ACH12421 | K103505 | 000 |
| M824ACH12401 | K103505 | 000 |
| M824ACH12381 | K103505 | 000 |
| M824ACH12361 | K103505 | 000 |
| M824ACH11081 | K103505 | 000 |
| 00193082000560 | K103505 | 000 |
| 00193082000416 | K103505 | 000 |
| 00193082000409 | K103505 | 000 |
| 00193082000393 | K103505 | 000 |
| 00193082000386 | K103505 | 000 |
| 00193082000379 | K103505 | 000 |
| 00193082000362 | K103505 | 000 |
| 00193082000355 | K103505 | 000 |
| 00193082000348 | K103505 | 000 |
| 00193082000331 | K103505 | 000 |
| 00193082000324 | K103505 | 000 |
| 00193082000317 | K103505 | 000 |
| 00193082000300 | K103505 | 000 |
| 00193082000423 | K103505 | 000 |
| 00193082000430 | K103505 | 000 |
| 00193082000553 | K103505 | 000 |
| 00193082000546 | K103505 | 000 |
| 00193082000539 | K103505 | 000 |
| 00193082000522 | K103505 | 000 |
| 00193082000515 | K103505 | 000 |
| 00193082000508 | K103505 | 000 |
| 00193082000492 | K103505 | 000 |
| 00193082000485 | K103505 | 000 |
| 00193082000478 | K103505 | 000 |
| 00193082000461 | K103505 | 000 |
| 00193082000454 | K103505 | 000 |
| 00193082000447 | K103505 | 000 |
| 00193082000294 | K103505 | 000 |
| 00193082000287 | K103505 | 000 |
| 00193082000133 | K103505 | 000 |
| 00193082000126 | K103505 | 000 |
| 00193082000119 | K103505 | 000 |
| 00193082000102 | K103505 | 000 |
| 00193082000096 | K103505 | 000 |
| 00193082000089 | K103505 | 000 |
| 00193082000072 | K103505 | 000 |
| 00193082000065 | K103505 | 000 |
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| 00193082000041 | K103505 | 000 |
| 00193082000034 | K103505 | 000 |
| 00193082000027 | K103505 | 000 |
| 00193082000140 | K103505 | 000 |
| 00193082000157 | K103505 | 000 |
| 00193082000270 | K103505 | 000 |
| 00193082000263 | K103505 | 000 |
| 00193082000256 | K103505 | 000 |
| 00193082000249 | K103505 | 000 |
| 00193082000232 | K103505 | 000 |
| 00193082000225 | K103505 | 000 |
| 00193082000218 | K103505 | 000 |
| 00193082000201 | K103505 | 000 |
| 00193082000195 | K103505 | 000 |
| 00193082000188 | K103505 | 000 |
| 00193082000171 | K103505 | 000 |
| 00193082000164 | K103505 | 000 |
| 00193082000010 | K103505 | 000 |