510(k) K934366
- Device
- MITEK CANCELLOUS FIXATION SCREW, CORTICAL FIXATION SCREW, SOFT TISSUE WASHER
- Applicant
- MITEK SURGICAL PRODUCTS, INC.
- 510(k) number
- K934366
- Product code
- HWC
- Decision
- Substantially Equivalent For Some Indications (SN)
- Decision date
- 1994-10-07
- Date received
- 1993-09-07
- Regulation
- 888.3040
- Classification name
- Screw, Fixation, Bone
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBERT P ZOLETTI
- Address
- 57 Providence Hwy. Norwood MA US 02062 02062
FDA Registration Numbers#
- 3043620689
- 3014315560
- 3009217531
- 3005497913
- 9614438
- 3011500362
- 3027339877
- 3010047454
- 1222773
- 3006639944
- 1226544
- 9681465
- 1833986
- 3009923578
- 1320894
- 3007113169
- 3014554088
- 3015398319
- 3006783837
- 2027148
- 3010120339
- 2183785
- 1000461041
- 3022928161
- 1221934
- 3008559295
- 3019767615
- 1647149
- 3003477135
- 1060840
- 3027242374
- 3012447612
- 3006395932
- 3016084569
- 3016537375
- 3007334927
- 2528981
- 9610921
- 3009971621
- 3015895045
- 3015531529
- 1225838
- 3013055499
- 3017209758
- 3013820441
- 3008599979
- 3010068573
- 3010132111
- 3017565094
- 3013767421
- 3038503932
- 2530154
- 3018094310
- 1226425
- 3011015572
- 3015869493
- 3010407203
- 3007700286
- 1061927
- 3038776593
- 2648920
- 3011943495
- 3001239363
- 3003525643
- 3006638824
- 3030271054
- 3007441485
- 3011683674
- 3008583793
- 3012724179
- 3032588003
- 3007051929
- 3015167917
- 3029933740
- 3017210488
- 1835296
- 1720929
- 3010060157
- 3034532468
- 3003541440
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code HWC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K254077 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO , Ltd. | 2026-05-01 |
| K260934 | TITAN Nail; APTUS K-Wire System | Medartis AG | 2026-04-17 |
| K252699 | CoAptix S System | University of Utah, Department of Orthopaedics | 2026-04-10 |
| K253042 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2026-04-03 |
| K254110 | DynaNail Mini; DynaNail Hybrid; DynaNail Helix; DynaClip; DynaClip Forte; DynaClip Delta; DynaClip Quattro | MedShape, Inc. | 2026-03-18 |
Legacy Summary#
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FDA Review#
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