510(k) K161259
- Device
- KLS Martin Cannulated Headless Screws
- Applicant
- KLS MARTIN LP
- 510(k) number
- K161259
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2016-12-19
- Date received
- 2016-05-04
- 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
- JENNIFER DAMATO
- Address
- 11201 Saint Johns Industrial Pkwy. S Jacksonville FL US 32246 32246
FDA Registration Numbers#
- 3017597868
- 3005029036
- 3009158523
- 3015978338
- 3020899789
- 3008824097
- 3022472578
- 2249615
- 3002579136
- 3024813436
- 3014279513
- 1320894
- 3014976005
- 3011500362
- 1424434
- 1644408
- 3011137372
- 3016247852
- 3030271054
- 1043534
- 3013561205
- 9610921
- 3002806470
- 3025603301
- 3022295665
- 3014104093
- 3009217531
- 3004748528
- 3005497913
- 3013700547
- 2650143
- 3034676720
- 3011053036
- 3007441485
- 3009756153
- 1064129
- 3036042032
- 3014655115
- 2032521
- 3005874553
- 9611112
- 3006128100
- 3015869492
- 3006217744
- 2437731
- 3043026734
- 3011296511
- 3009394448
- 3009998573
- 9611827
- 9680825
- 1220246
- 1720929
- 1319429
- 3014522470
- 3013365802
- 9616680
- 3010173425
- 3020584246
- 8010099
- 3016112537
- 3010287665
- 1835251
- 3013843055
- 3010120339
- 3002808145
- 1835444
- 3016759112
- 3017191784
- 1724955
- 3000270450
- 3006001176
- 9615128
- 3010041499
- 3010646402
- 3015724777
- 2183967
- 3016660811
- 3010178296
- 3010863450
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#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases