510(k) K973836
- Device
- SYNERGY 6.35MM SS ROD WITH SCREWS FOR ANTERIOR USE, PART OF THE CROSS MEDICAL-SYNERGY ANTERIOR SPINAL SYSTEM
- Applicant
- CROSS MEDICAL PRODUCTS, INC.
- 510(k) number
- K973836
- Product code
- MNH
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1998-03-05
- Date received
- 1997-10-08
- Regulation
- 888.3070
- Classification name
- Orthosis, Spondylolisthesis Spinal Fixation
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- PHIL MELLINGER
- Address
- 5160-A Blazer Pkwy. Suite A Dublin OH US 43017 43017
FDA Registration Numbers#
- 3003935342
- 1223434
- 3011221483
- 1722511
- 3010160527
- 3010606097
- 3009882675
- 1835572
- 3008455034
- 8020776
- 3009173317
- 3030412764
- 3023265483
- 3011577940
- 3007993775
- 3015941638
- 9614209
- 3007675554
- 3006378738
- 3002808227
- 3005596514
- 3010123206
- 3010370500
- 3008992889
- 3006460162
- 3003639920
- 3004719693
- 3013055499
- 3014763043
- 2183449
- 3010866843
- 3013011598
- 3012329926
- 3010041430
- 3011874600
- 3015831087
- 3013548554
- 3006563559
- 3002976036
- 9616944
- 2134470
- 3009165919
- 9616062
- 1720929
- 1526534
- 1000493591
- 9611813
- 3007887127
- 3019837678
- 1828288
- 3012863589
- 9617297
- 3009050824
- 1834331
- 1056553
- 3009888740
- 3010531060
- 1000200989
- 9681642
- 3014725904
- 3008110533
- 3011796723
- 3009106092
- 3011277306
- 3004638532
- 1225838
- 3008812560
- 3009110133
- 3008850074
- 1935627
- 3004499989
- 3008285983
- 3009959868
- 3016438694
- 3033509898
- 3010370880
- 3004635447
- 2133687
- 3004176895
- 3011513267
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MNH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162066 | Reliance Spinal Screw System | Reliance Medical Systems, LLC | 2016-12-02 |
| K162801 | CastleLoc Spinal Fixation System | L&K BIOMED Co., Ltd. | 2016-11-03 |
| K162143 | FixxSure® X-Link | Innovasis, Inc. | 2016-09-23 |
| K161151 | Spinal fixation system | Canwell Medical Co., Ltd. | 2016-09-21 |
| K162189 | ANAX™ 5.5 Spinal System | U&I Corporation | 2016-08-30 |
| K151362 | HC Spinal System | Hung Chun Bio-S Co., Ltd. | 2016-05-05 |
| K153404 | Zavation Spinal System | Zavation, LLC | 2016-04-21 |
| K160020 | Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | 2016-03-02 |
| K143013 | Spinal Inner Fixation System | Changzhou Dingjian Medical Appliance Co., Ltd. | 2015-12-11 |
| K151695 | Romeo posterior osteosynthesis system | Spineart | 2015-09-10 |
| K151116 | CapLOX II/TowerLOX Pedicle Screw System | Captiva Spine | 2015-06-26 |
| K150283 | Republic Spine Dark Star Spinal System | Republic Spine, LLC | 2015-04-29 |
| K142798 | PASS LP Spinal System | Medicrea International SA | 2015-03-25 |
| K143417 | ANAX 5.5 Spinal System | U&I Corporation | 2015-02-25 |
| K143377 | PedFuse Pedicle Screw System | Spinefrontier, Inc. | 2015-02-12 |
Legacy Summary#
summary
FDA Review#
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