PACP

Appliance, Fixation, Spinal Intervertebral Body

PIONEER SURGICAL TECHNOLOGY

The following data is part of a premarket notification filed by Pioneer Surgical Technology with the FDA for Pacp.

Pre-market Notification Details

• Device ID: K083663
• 510k Number: K083663
• Device Name: PACP
• Classification: Appliance, Fixation, Spinal Intervertebral Body
• Applicant: PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627
• Contact: Jonathan Gilbert
• Correspondent: Jonathan Gilbert; PIONEER SURGICAL TECHNOLOGY 375 RIVER PARK CIRCLE Marquette, MI 49855 -0627
• Product Code: KWQ
• CFR Regulation Number: 888.3060 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-12-10
• Decision Date: 2009-02-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00846468023621	K083663	000
00846468023904	K083663	000
00846468023898	K083663	000
00846468023881	K083663	000
00846468023874	K083663	000
00846468023867	K083663	000
00846468023850	K083663	000
00846468023843	K083663	000
00846468023836	K083663	000
00846468023911	K083663	000
00846468023928	K083663	000
00846468024000	K083663	000
00846468023997	K083663	000
00846468023980	K083663	000
00846468023973	K083663	000
00846468023966	K083663	000
00846468023959	K083663	000
00846468023942	K083663	000
00846468023935	K083663	000
00846468023829	K083663	000
00846468023812	K083663	000
00846468023706	K083663	000
00846468023690	K083663	000
00846468023683	K083663	000
00846468023676	K083663	000
00846468023669	K083663	000
00846468023652	K083663	000
00846468023645	K083663	000
00846468023638	K083663	000
00846468023713	K083663	000
00846468023720	K083663	000
00846468023805	K083663	000
00846468023799	K083663	000
00846468023782	K083663	000
00846468023775	K083663	000
00846468023768	K083663	000
00846468023751	K083663	000
00846468023744	K083663	000
00846468023737	K083663	000
00846468024017	K083663	000
00846468024024	K083663	000
00846468024031	K083663	000
00846468024314	K083663	000
00846468024307	K083663	000
00846468024291	K083663	000
00846468024284	K083663	000
00846468024277	K083663	000
00846468024260	K083663	000
00846468024253	K083663	000
00846468024246	K083663	000
00846468024321	K083663	000
00846468024338	K083663	000
00846468024413	K083663	000
00846468024406	K083663	000
00846468024390	K083663	000
00846468024383	K083663	000
00846468024376	K083663	000
00846468024369	K083663	000
00846468024352	K083663	000
00846468024345	K083663	000
00846468024239	K083663	000
00846468024222	K083663	000
00846468024116	K083663	000
00846468024109	K083663	000
00846468024093	K083663	000
00846468024086	K083663	000
00846468024079	K083663	000
00846468024062	K083663	000
00846468024055	K083663	000
00846468024048	K083663	000
00846468024123	K083663	000
00846468024130	K083663	000
00846468024215	K083663	000
00846468024208	K083663	000
00846468024192	K083663	000
00846468024185	K083663	000
00846468024178	K083663	000
00846468024161	K083663	000
00846468024154	K083663	000
00846468024147	K083663	000
00846468024420	K083663	000