CAPLESS PEDICLE SCREW SYSTEM

Orthosis, Spinal Pedicle Fixation

X-SPINE SYSTEMS, INC.

The following data is part of a premarket notification filed by X-spine Systems, Inc. with the FDA for Capless Pedicle Screw System.

Pre-market Notification Details

• Device ID: K052847
• 510k Number: K052847
• Device Name: CAPLESS PEDICLE SCREW SYSTEM
• Classification: Orthosis, Spinal Pedicle Fixation
• Applicant: X-SPINE SYSTEMS, INC. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130
• Contact: Floyd G Larson
• Correspondent: Floyd G Larson; X-SPINE SYSTEMS, INC. 11234 EL CAMINO REAL SUITE 200 San Diego, CA 92130
• Product Code: MNI
• CFR Regulation Number: 888.3070 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-10-07
• Decision Date: 2005-12-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
M697N60000352DL1	K052847	000
M697N600006001	K052847	000
M697N60000600DL1	K052847	000
M697N600006011	K052847	000
M697N60000601DL1	K052847	000
M697N600006021	K052847	000
M697N60000602DL1	K052847	000
M697N600006031	K052847	000
M697N60000603DL1	K052847	000
M697N600006041	K052847	000
M697N600004151	K052847	000
M697N600004141	K052847	000
M697N600004131	K052847	000
M697N600004041	K052847	000
M697N600004051	K052847	000
M697N600004061	K052847	000
M697N600004071	K052847	000
M697N600004081	K052847	000
M697N600004091	K052847	000
M697N600004101	K052847	000
M697N600004111	K052847	000
M697N600004121	K052847	000
M697N60000604DL1	K052847	000
M697N600006051	K052847	000
M697N60000611DL1	K052847	000
M697N600006121	K052847	000
M697N60000612DL1	K052847	000
M697N600006131	K052847	000
M697N60000613DL1	K052847	000
M697N600006141	K052847	000
M697N60000614DL1	K052847	000
M697N600006151	K052847	000
M697N60000615DL1	K052847	000
M697N600006111	K052847	000
M697N60000610DL1	K052847	000
M697N600006101	K052847	000
M697N60000605DL1	K052847	000
M697N600006061	K052847	000
M697N60000606DL1	K052847	000
M697N600006071	K052847	000
M697N60000607DL1	K052847	000
M697N600006081	K052847	000
M697N60000608DL1	K052847	000
M697N600006091	K052847	000
M697N60000609DL1	K052847	000
M697N600006161	K052847	000
M697N600003521	K052847	000
M697N600003151	K052847	000
M697N60000325DL1	K052847	000
M697N600003261	K052847	000
M697N60000326DL1	K052847	000
M697N600003271	K052847	000
M697N60000327DL1	K052847	000
M697N600003281	K052847	000
M697N60000328DL1	K052847	000
M697N600003291	K052847	000
M697N60000329DL1	K052847	000
M697N600003251	K052847	000
M697N60000320DL1	K052847	000
M697N600003201	K052847	000
M697N60000315DL1	K052847	000
M697N600003161	K052847	000
M697N60000316DL1	K052847	000
M697N600003171	K052847	000
M697N60000317DL1	K052847	000
M697N600003181	K052847	000
M697N60000318DL1	K052847	000
M697N600003191	K052847	000
M697N60000319DL1	K052847	000
M697N600003301	K052847	000
M697N60000330DL1	K052847	000
M697N600003411	K052847	000
M697N60000341DL1	K052847	000
M697N600003421	K052847	000
M697N60000342DL1	K052847	000
M697N600003431	K052847	000
M697N60000343DL1	K052847	000
M697N600003501	K052847	000
M697N60000350DL1	K052847	000
M697N600003511	K052847	000
M697N60000340DL1	K052847	000
M697N600003401	K052847	000
M697N60000339DL1	K052847	000
M697N600003351	K052847	000
M697N60000335DL1	K052847	000
M697N600003361	K052847	000
M697N60000336DL1	K052847	000
M697N600003371	K052847	000
M697N60000337DL1	K052847	000
M697N600003381	K052847	000
M697N60000338DL1	K052847	000
M697N600003391	K052847	000
M697N60000351DL1	K052847	000
M697N60000616DL1	K052847	000
M697N60001041DL1	K052847	000
M697N605535SDDL1	K052847	000
M697N605540SD1	K052847	000
M697N605540SDDL1	K052847	000
M697N605545SD1	K052847	000
M697N605545SDDL1	K052847	000
M697N605550SD1	K052847	000
M697N605550SDDL1	K052847	000
M697N605555SD1	K052847	000
M697N605555SDDL1	K052847	000
M697N605535SD1	K052847	000
M697N605530SDDL1	K052847	000
M697N605530SD1	K052847	000
M697N600010821	K052847	000
M697N600010831	K052847	000
M697N600010841	K052847	000
M697N600010851	K052847	000
M697N600010861	K052847	000
M697N600010871	K052847	000
M697N600010881	K052847	000
M697N600010891	K052847	000
M697N600010901	K052847	000
M697N606530SD1	K052847	000
M697N606530SDDL1	K052847	000
M697N607535SD1	K052847	000
M697N607535SDDL1	K052847	000
M697N607540SD1	K052847	000
M697N607540SDDL1	K052847	000
M697N607545SD1	K052847	000
M697N607545SDDL1	K052847	000
M697N607550SD1	K052847	000
M697N607550SDDL1	K052847	000
M697N607555SD1	K052847	000
M697N607530SDDL1	K052847	000
M697N607530SD1	K052847	000
M697N606555SDDL1	K052847	000
M697N606535SD1	K052847	000
M697N606535SDDL1	K052847	000
M697N606540SD1	K052847	000
M697N606540SDDL1	K052847	000
M697N606545SD1	K052847	000
M697N606545SDDL1	K052847	000
M697N606550SD1	K052847	000
M697N606550SDDL1	K052847	000
M697N606555SD1	K052847	000
M697N607555SDDL1	K052847	000
M697N600010411	K052847	000
M697N600006171	K052847	000
M697N60000623DL1	K052847	000
M697N600006241	K052847	000
M697N60000624DL1	K052847	000
M697N600006251	K052847	000
M697N60000625DL1	K052847	000
M697N600006261	K052847	000
M697N60000626DL1	K052847	000
M697N600006271	K052847	000
M697N60000627DL1	K052847	000
M697N600006231	K052847	000
M697N60000622DL1	K052847	000
M697N600006221	K052847	000
M697N60000617DL1	K052847	000
M697N600006181	K052847	000
M697N60000618DL1	K052847	000
M697N600006191	K052847	000
M697N60000619DL1	K052847	000
M697N600006201	K052847	000
M697N60000620DL1	K052847	000
M697N600006211	K052847	000
M697N60000621DL1	K052847	000
M697N600006281	K052847	000
M697N60000628DL1	K052847	000
M697N600010361	K052847	000
M697N60001036DL1	K052847	000
M697N600010371	K052847	000
M697N60001037DL1	K052847	000
M697N600010381	K052847	000
M697N60001038DL1	K052847	000
M697N600010391	K052847	000
M697N60001039DL1	K052847	000
M697N600010401	K052847	000
M697N600009231	K052847	000
M697N600009221	K052847	000
M697N600009211	K052847	000
M697N600006291	K052847	000
M697N60000629DL1	K052847	000
M697N600009141	K052847	000
M697N600009151	K052847	000
M697N600009161	K052847	000
M697N600009171	K052847	000
M697N600009181	K052847	000
M697N600009191	K052847	000
M697N600009201	K052847	000
M697N60001040DL1	K052847	000