Product Code: MNI


Products Classified as MNI

4624Orthosis, Spinal Pedicle FixationThoracolumbosacral Pedicle Screw System.

Total Product Life Cycle (TPLC) Devices

4624Orthosis, Spinal Pedicle FixationThoracolumbosacral Pedicle Screw System.

FDA Consensus Standards

Orthosis, Spinal Pedicle Fixation [37410]21 CFR §888.3070 🔎
Orthosis, Spinal Pedicle Fixation [37411]21 CFR §888.3070 🔎
Orthosis, Spinal Pedicle Fixation [35610]21 CFR §888.3070 🔎
Orthosis, Spinal Pedicle Fixation [37829]21 CFR §888.3070 🔎
Orthosis, Spinal Pedicle Fixation [38313]21 CFR §888.3070 🔎
Orthosis, Spinal Pedicle Fixation [38312]21 CFR §888.3070 🔎
Orthosis, Spinal Pedicle Fixation [37861]21 CFR §888.3070 🔎
Orthosis, Spinal Pedicle Fixation [32387]21 CFR §888.3070 🔎
Orthosis, Spinal Pedicle Fixation [37390]21 CFR §888.3070 🔎
Orthosis, Spinal Pedicle Fixation [34069]21 CFR §888.3070 🔎

Pre-market Notifications for MNI

K171497Mikron Spinal Fixation SystemMikron Makina Sanayi Ticaret Co. Ltd.
K160731LumFix Spinal Fixation SytemCG BIO CO., LTD.
K160320PremierShandong Weigao Orthopaedic Device Co., Ltd
K160124LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation SystemSpineVision S.A.
K160003Sniper (R) Spine SystemSPINE WAVE, INC.
K153273MySpine Pedicle Screw Placement Guides - LPMedacta International SA
K152324YAHUA Spinal SystemBEIJING WEIGAO YAHUA ARTIFICIAL JOINT DEVELOPMENT CO. LTD.
K152174Sniper Spine SystemSPINE WAVE, INC.
K152132X-spine Pedicle Screw SystemX-spine Systems, Inc.
K152131Reliance Spinal Screw SystemReliance Medical Systems, LLC
K152098ODALYS Pedicle Screw SystemKisco International
K151813Sniper Spine SystemSPINE WAVE, INC.
K151592Gemmed Pedicle Screw Spinal SystemSUZHOU GEMMED MEDICAL INSTRUMENT CO., LTD.
K151458Double Medical Universal Spine SystemDouble Medical Technology Inc
K150684WASTON General Spinal SystemCHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD

Global Unique Device Identification Database

00613994953216ORTHOSIS, SPINAL PEDICLE FIXATION
00613994953193ORTHOSIS, SPINAL PEDICLE FIXATION
00613994953186ORTHOSIS, SPINAL PEDICLE FIXATION
00613994950956ORTHOSIS, SPINAL PEDICLE FIXATION
00613994950864ORTHOSIS, SPINAL PEDICLE FIXATION
00613994950833ORTHOSIS, SPINAL PEDICLE FIXATION
00613994950819ORTHOSIS, SPINAL PEDICLE FIXATION
00613994950802ORTHOSIS, SPINAL PEDICLE FIXATION
00613994950796ORTHOSIS, SPINAL PEDICLE FIXATION
00613994950741ORTHOSIS, SPINAL PEDICLE FIXATION
00613994950574ORTHOSIS, SPINAL PEDICLE FIXATION
00613994950420ORTHOSIS, SPINAL PEDICLE FIXATION
00613994950345ORTHOSIS, SPINAL PEDICLE FIXATION
00613994949998ORTHOSIS, SPINAL PEDICLE FIXATION
00613994949981ORTHOSIS, SPINAL PEDICLE FIXATION

Maude Adverse Events

UNK - STENOFIXOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - STENOFIXOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-31
UNK - STENOFIXOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-17
EXPEDIUM SPINE SYSTEM ROD 5.5 X 300MMMEDOS INTERNATIONAL SàRL CH2020-03-17
S4 SET SCREW NEW VERSIONAESCULAP AG2020-03-17
5.5 EXP VERSE FEN SCR 7.0X45MEDOS INTERNATIONAL SàRL CH2020-03-16
5.5 EXP VERSE FEN SCR 7.0X45MEDOS INTERNATIONAL SàRL CH2020-03-16
UNK - VERTEBRAL BODY REPLACEMENT - EXPANDABLEOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-16
UNK - VERTEBRAL BODY REPLACEMENT - EXPANDABLE: XRLOBERDORF SYNTHES PRODUKTIONS GMBH2020-03-16
UNKNOWN_K2M_PRODUCTK2M, INC.2020-03-14
S4 SET SCREW NEW VERSIONAESCULAP AG2020-03-13
VIPER SYSTEM FENESTRATED CORTICAL FIX POLYAXIAL SCREW 5.5 X 8 X 50MMMEDOS INTERNATIONAL SàRL CH2020-03-11
EXP 4.5 TI SINGLE INNIEMEDOS INTERNATIONAL SàRL CH2020-03-10
EXP 4.5 TI SINGLE INNIEMEDOS INTERNATIONAL SàRL CH2020-03-10
MYSPINE MYSPINE LP DRILL PILOT GUIDE L04MEDACTA INTERNATIONAL SA2020-03-06
XPRESS MINIMALLY INVASIVE PEDICLE SCREW SYSTEMX-SPINE SYSTEMS, INC.2020-03-05
MIS TI CFX FEN POLY 8X50MEDOS INTERNATIONAL SàRL CH2020-03-03
S4 SET SCREW NEW VERSIONAESCULAP AG2020-02-26
S4 SET SCREW NEW VERSIONAESCULAP AG2020-02-26
S4 SET SCREW NEW VERSIONAESCULAP AG2020-02-26
S4 SET SCREW NEW VERSIONAESCULAP AG2020-02-26
TILOCK PEDICLE SCREW SYSTEMGENESYS SPINE2020-02-18
S4 SET SCREW NEW VERSIONAESCULAP AG2020-02-12
S4 SET SCREW NEW VERSIONAESCULAP AG2020-02-12
EXPEDIUM VERSE SPINE SYS FENESTRATED CORTICAL FIX POLY SCREW 5.5 5.0 X 50MMMEDOS INTERNATIONAL SàRL CH2020-02-12
CD HORIZON SOLERA FENESTRATED SCREW SPINAL SYSTEMMDT SOFAMOR DANEK PUERTO RICO MFG2020-02-11
MNTR OC PLATE SMALLMEDOS INTERNATIONAL SàRL CH2020-02-07
CREOGLOBUS MEDICAL, INC.2020-02-05
UNKNOWN LAMINA/PEDICLE/PROCESS HOOKSMEDOS INTERNATIONAL SàRL CH2020-01-31
UNKNOWN LAMINA/PEDICLE/PROCESS HOOKSMEDOS INTERNATIONAL SàRL CH2020-01-31
UNKNOWN LAMINA/PEDICLE/PROCESS HOOKSMEDOS INTERNATIONAL SàRL CH2020-01-31
X-SPINE PEDICLE SCREW SYSTEMX-SPINE SYSTEMS, INC.2020-01-17
5.5 EXP VERSE FEN SCR 7.0X50MEDOS INTERNATIONAL SàRL CH2020-01-08
ORTHOSIS, SPINAL PEDICLE FIXATIONRELIANCE MEDICAL SYSTEMS, LLC2020-01-03
5.5 EXP VERSE FEN SCR 7.0X50MEDOS INTERNATIONAL SàRL CH2019-11-27
PASS LPMEDICREA INTERNATIONAL2019-11-22
UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIESDEPUY SPINE INC2019-11-12
UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIESDEPUY SPINE INC2019-11-12
UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIESDEPUY SPINE INC2019-11-12
UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIESDEPUY SPINE INC2019-11-12
UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIESDEPUY SPINE INC2019-11-12
UNKNOWN SCREW/ROD CONSTRUCT ACCESSORIESDEPUY SPINE INC2019-11-12
DYNESYS, HA PEDICLE SCREW + SET SCREW, 6.0X40ZIMMER GMBH2019-11-11
UNK - DISTRACTOR IMPLANTSOBERDORF SYNTHES PRODUKTIONS GMBH2019-11-04
UNK - DISTRACTOR IMPLANTSOBERDORF SYNTHES PRODUKTIONS GMBH2019-11-04
TILOCK PEDICLE SCREW SYSTEMGENESYS SPINE2019-10-30
TILOCK PEDICLE SCREW SYSTEMGENESYS SPINE2019-10-28
UNKNOWN SCREWSMEDOS INTERNATIONAL SàRL CH2019-10-25
EXP TI UNI SCREW 7MM X 45MMMEDOS INTERNATIONAL SàRL CH2019-10-18
EXP TI UNI SCREW 6MM X 45MMMEDOS INTERNATIONAL SàRL CH2019-10-18
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