510(k) K014153
- Device
- COAPT SYSTMES ENDOTINE DEVICE
- Applicant
- COAPT SYSTEMS, INC.
- 510(k) number
- K014153
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-03-15
- Date received
- 2001-12-18
- Regulation
- 888.3040
- Classification name
- Screw, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JUDE PAGANELLI
- Address
- 261 Hamilton Ave. Suite 413 Palo Alto CA US 94301 94301
FDA Registration Numbers#
- 3005064037
- 3011580264
- 3010593798
- 1226544
- 3023265483
- 9614438
- 3007051929
- 3006801265
- 3010047402
- 3030514683
- 3007993775
- 3013280419
- 3027827832
- 3038503572
- 3014527928
- 3019923333
- 3003139373
- 3006846753
- 3009871135
- 3035373797
- 3010400367
- 3006563559
- 3010470577
- 3004187715
- 3022777867
- 3021336182
- 2031009
- 3015869121
- 3011230048
- 3043543260
- 3011295718
- 3026576110
- 3010375065
- 3030271054
- 3010370880
- 3010646402
- 2531477
- 3036756245
- 3034676720
- 3010039400
- 3013540005
- 3011127597
- 1828288
- 1038671
- 1219655
- 3027242374
- 3016112537
- 3003755939
- 3009882462
- 3010673777
- 3022518322
- 1036836
- 3023189283
- 3015978338
- 3006217744
- 1421101
- 3010120326
- 3007913880
- 3013176080
- 2531195
- 3007113169
- 2530808
- 2028632
- 3009423112
- 2183967
- 1222928
- 3010132111
- 2030624
- 3027339877
- 3015869492
- 3010041993
- 3010120135
- 3008110533
- 3010363503
- 2320767
- 3011053036
- 3008034554
- 3017565094
- 3007109793
- 3017191784
Source Documents#
Other 510(k) Records For Product Code HWC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261961 | Ntegrate Threaded Nail System | Nvision Biomedical Technologies | 2026-10-14 |
| K263116 | OsteoCentric Technologies Cannulated and Soild Fasteners with Nuts | OsteoCentric Technologies | 2026-10-02 |
| K262975 | Arthrex Beaming System | Arthrex, Inc. | 2026-09-25 |
| K260995 | DynaNail Helix® Fixation System | MedShape, Inc. | 2026-09-23 |
| K254280 | F.A.S.T Screw | Steps Ortho | 2026-09-21 |
| K261057 | ActivaScrew™ Cannulated COM | Bioretec, Ltd. | 2026-09-04 |
| K260106 | OsteoCoil™ GT Active Compression System | Flower Orthopedics Corporation DBA Conventus Flower Orthoped | 2026-08-24 |
| K262344 | Large Compression Screws | TriMed, Inc. | 2026-08-12 |
| K253858 | GFS - Sterile Screws and Top Hat | T.A.G. Medical Products Corporation, Ltd. | 2026-08-05 |
| K262075 | Lapidus Screw Kit | Relja Innovations, LLC | 2026-07-22 |
| K260809 | Arthrex Sterile VAL and VAL KreuLock™ Compression Screw System | Arthrex, Inc. | 2026-06-25 |
| K253108 | VEOFIX Snap Off Screw | Steps Ortho | 2026-06-05 |
| K261154 | CoLink® & CoLag® Non-Sterile Screws | In2Bones USA, LLC | 2026-05-30 |
| K261241 | TriMed Compression Screws | TriMed, Inc. | 2026-05-14 |
| K254215 | Arthrex Beaming System | Arthrex, Inc. | 2026-05-08 |
Legacy Summary#
summary
FDA Review#
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