APEX SPINE SYSTEM W/ COCR RODS

Orthosis, Spondylolisthesis Spinal Fixation

SPINECRAFT LLC

The following data is part of a premarket notification filed by Spinecraft Llc with the FDA for Apex Spine System W/ Cocr Rods.

Pre-market Notification Details

• Device ID: K102488
• 510k Number: K102488
• Device Name: APEX SPINE SYSTEM W/ COCR RODS
• Classification: Orthosis, Spondylolisthesis Spinal Fixation
• 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: MNH
• Subsequent Product Code: KWP
• Subsequent Product Code: KWQ
• Subsequent Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-08-31
• Decision Date: 2010-12-10
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M8246000CR0301	K102488	000
M8245500CR0501	K102488	000
M8245500CR0401	K102488	000
M8245500CR0301	K102488	000
M824SS6T30XL1	K102488	000
M824SS6T30L1	K102488	000
M824SC6000CR600D1	K102488	000
M824SC6000CR6001	K102488	000
M824SC6000CR450D1	K102488	000
M8245500CR0601	K102488	000
M8245500CR0701	K102488	000
M8245500CR0801	K102488	000
M8245500CR600D1	K102488	000
M8245500CR6001	K102488	000
M8245500CR450D1	K102488	000
M8245500CR4501	K102488	000
M8245500CR3251	K102488	000
M8245500CR300D1	K102488	000
M8245500CR3001	K102488	000
M8245500CR0901	K102488	000
M824SC6000CR4501	K102488	000
M824SC6000CR300D1	K102488	000
M824SC6000CR3001	K102488	000
M824SC5500CR300D1	K102488	000
M824SC5500CR3001	K102488	000
M824SC5500CR0901	K102488	000
M824SC5500CR0801	K102488	000
M824SC5500CR0701	K102488	000
M824SC5500CR0601	K102488	000
M824SC5500CR0501	K102488	000
M824SC5500CR0401	K102488	000
M824SC5500CR4501	K102488	000
M824SC5500CR450D1	K102488	000
M824SC5500CR6001	K102488	000
M824SC6000CR0901	K102488	000
M824SC6000CR0801	K102488	000
M824SC6000CR0701	K102488	000
M824SC6000CR0601	K102488	000
M824SC6000CR0501	K102488	000
M824SC6000CR0401	K102488	000
M824SC6000CR0301	K102488	000
M824SC5500CR600D1	K102488	000
M824SC5500CR0301	K102488	000
00193082004384	K102488	000
00193082004261	K102488	000
00193082004254	K102488	000
00193082004247	K102488	000
00193082004230	K102488	000
00193082004223	K102488	000
00193082004216	K102488	000
00193082004209	K102488	000
00193082004193	K102488	000
00193082004278	K102488	000
00193082004285	K102488	000
00193082004292	K102488	000
00193082004377	K102488	000
00193082004360	K102488	000
00193082004353	K102488	000
00193082004346	K102488	000
00193082004339	K102488	000
00193082004322	K102488	000
00193082004315	K102488	000
00193082004308	K102488	000
00193082004186	K102488	000
00193082004179	K102488	000
00193082004162	K102488	000
M8246000CR3251	K102488	000
M8246000CR300D1	K102488	000
M8246000CR3001	K102488	000
M8246000CR0901	K102488	000
M8246000CR0801	K102488	000
M8246000CR0701	K102488	000
M8246000CR0601	K102488	000
M8246000CR0501	K102488	000
M8246000CR4501	K102488	000
M8246000CR450D1	K102488	000
M8246000CR6001	K102488	000
00193082004155	K102488	000
00193082004148	K102488	000
00193082004131	K102488	000
00193082004124	K102488	000
00193082004117	K102488	000
00193082004100	K102488	000
00193082004094	K102488	000
M8246000CR600D1	K102488	000
M8246000CR0401	K102488	000