VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM

Retractor, Self-retaining, For Neurosurgery

V. MUELLER NEURO/SPINE

The following data is part of a premarket notification filed by V. Mueller Neuro/spine with the FDA for Versatrac (tm) Lumbar Retractor System.

Pre-market Notification Details

• Device ID: K964402
• 510k Number: K964402
• Device Name: VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM
• Classification: Retractor, Self-retaining, For Neurosurgery
• Applicant: V. MUELLER NEURO/SPINE 871 INDUSTRIAL RD. San Carlos, CA 94070
• Contact: Terry Johnson
• Correspondent: Terry Johnson; V. MUELLER NEURO/SPINE 871 INDUSTRIAL RD. San Carlos, CA 94070
• Product Code: GZT
• CFR Regulation Number: 882.4800 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-11-04
• Decision Date: 1997-01-23

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10885403117008	K964402	000
10885403116407	K964402	000
10885403116391	K964402	000
10885403116384	K964402	000
10885403116377	K964402	000
10885403116360	K964402	000
10885403116353	K964402	000
10885403116346	K964402	000
10885403116339	K964402	000
10885403116322	K964402	000
10885403116315	K964402	000
10885403116308	K964402	000
10885403116414	K964402	000
10885403116421	K964402	000
10885403116438	K964402	000
10885403116995	K964402	000
10885403116988	K964402	000
10885403116971	K964402	000
10885403116964	K964402	000
10885403116957	K964402	000
10885403116940	K964402	000
10885403116933	K964402	000
10885403116926	K964402	000
10885403116469	K964402	000
10885403116452	K964402	000
10885403116445	K964402	000
10885403116292	K964402	000
10885403116285	K964402	000
10885403116278	K964402	000
10885403116124	K964402	000
10885403116117	K964402	000
10885403116100	K964402	000
10885403116094	K964402	000
10885403116087	K964402	000
10885403116070	K964402	000
10885403116063	K964402	000
10885403116056	K964402	000
10885403116049	K964402	000
10885403116032	K964402	000
10885403140754	K964402	000
10885403116131	K964402	000
10885403116148	K964402	000
10885403116155	K964402	000
10885403116261	K964402	000
10885403116254	K964402	000
10885403116247	K964402	000
10885403116230	K964402	000
10885403116223	K964402	000
10885403116216	K964402	000
10885403116209	K964402	000
10885403116193	K964402	000
10885403116186	K964402	000
10885403116179	K964402	000
10885403116162	K964402	000
10885403140709	K964402	000
10885403175893	K964402	000
10885403118906	K964402	000
10885403117459	K964402	000
10885403117442	K964402	000
10885403117435	K964402	000
10885403117428	K964402	000
10885403117411	K964402	000
10885403117404	K964402	000
10885403117398	K964402	000
10885403117381	K964402	000
10885403117374	K964402	000
10885403117367	K964402	000
10885403137006	K964402	000
10885403137112	K964402	000
10885403137129	K964402	000
10885403175886	K964402	000
10885403175848	K964402	000
10885403175824	K964402	000
10885403175817	K964402	000
10885403175190	K964402	000
10885403175183	K964402	000
10885403137228	K964402	000
10885403137198	K964402	000
10885403137181	K964402	000
10885403137174	K964402	000
10885403137136	K964402	000
10885403117350	K964402	000
10885403117343	K964402	000
10885403117336	K964402	000
10885403117183	K964402	000
10885403117176	K964402	000
10885403117169	K964402	000
10885403117152	K964402	000
10885403117145	K964402	000
10885403117138	K964402	000
10885403117077	K964402	000
10885403117060	K964402	000
10885403117046	K964402	000
10885403117039	K964402	000
10885403117022	K964402	000
10885403117190	K964402	000
10885403117206	K964402	000
10885403117213	K964402	000
10885403117329	K964402	000
10885403117312	K964402	000
10885403117305	K964402	000
10885403117299	K964402	000
10885403117282	K964402	000
10885403117275	K964402	000
10885403117268	K964402	000
10885403117251	K964402	000
10885403117244	K964402	000
10885403117237	K964402	000
10885403117220	K964402	000
10885403117015	K964402	000