510(k) K013191
- Device
- PASS SPINAL SYSTEM
- Applicant
- ENCORE ORTHOPEDICS, INC.
- 510(k) number
- K013191
- Product code
- MNI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-10-24
- Date received
- 2001-09-24
- Regulation
- 888.3070
- Classification name
- Orthosis, Spinal Pedicle Fixation
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOANNA DROEGE
- Address
- 9800 Metric Blvd. Austin TX US 78758 78758
FDA Registration Numbers#
- 3009173317
- 3011390763
- 3014725904
- 3003541440
- 3005562917
- 3009973699
- 3010041430
- 1000200989
- 3005083075
- 3012863589
- 3009959868
- 1417485
- 1530390
- 3006783837
- 3007887127
- 3006404019
- 3004142400
- 3000170817
- 1724955
- 1221763
- 3015398319
- 3006215390
- 1319429
- 1528646
- 3004788213
- 3009468807
- 2531477
- 3017036472
- 3004153896
- 3007738812
- 1526439
- 3011187779
- 3014273424
- 3013491327
- 3010032903
- 1043653
- 2027467
- 1720929
- 3005739886
- 3011181154
- 3008534770
- 3012491394
- 3005874553
- 1835831
- 3037407500
- 1828464
- 3010326971
- 3004774118
- 3010531060
- 2032830
- 3007125392
- 9617544
- 3006984710
- 2028632
- 9681465
- 1835444
- 3010863450
- 3023265483
- 2530808
- 1000432246
- 3005977257
- 3006356043
- 3015941638
- 3013548554
- 3015869493
- 3006404071
- 3001239363
- 3005076207
- 1836357
- 3010462278
- 3011796723
- 2133687
- 1833920
- 3018094310
- 1643817
- 1824313
- 3008812560
- 3010365473
- 1526534
- 3009973505
Source Documents#
Other 510(k) Records For Product Code MNI #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171497 | Mikron Spinal Fixation System | Mikron Makina Sanayi Ticaret Co. , Ltd. | 2017-10-12 |
| K160731 | LumFix Spinal Fixation Sytem | CG Bio Co., Ltd. | 2016-10-04 |
| K151458 | Double Medical Universal Spine System | Double Medical Technology, Inc. | 2016-08-22 |
| K153273 | MySpine Pedicle Screw Placement Guides - LP | Medacta International S.A. | 2016-06-29 |
| K160124 | LUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation System | Spinevision S.A. | 2016-04-04 |
| K160320 | Premier | Shandong Weigao Orthopaedic Device Co., Ltd. | 2016-04-01 |
| K160003 | Sniper (R) Spine System | Spine Wave, Inc. | 2016-02-26 |
| K152324 | YAHUA Spinal System | Beijing Weigao Yahua Artificial Joint Development Co. , Ltd. | 2016-02-01 |
| K143222 | FIREFLY Pedicle Screw Navigation Guide | Mighty Oak Medical, Inc. | 2015-12-11 |
| K150684 | WASTON General Spinal System | Changzhou Waston Medical Appliance Co., Ltd. | 2015-11-18 |
| K152132 | X-spine Pedicle Screw System | X-Spine Systems, Inc. | 2015-09-25 |
| K151592 | Gemmed pedicle screw spinal system | Suzhou Gemmed Medical Instrument Co., Ltd. | 2015-09-24 |
| K152131 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2015-09-17 |
| K152098 | ODALYS Pedicle Screw System | Kisco International | 2015-09-17 |
| K152174 | Sniper Spine System | Spine Wave, Inc. | 2015-08-31 |
Legacy Summary#
summary
FDA Review#
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