510(k) K060830
- Device
- MILAGRO INTERFERENCE SCREW
- Applicant
- DEPUY MITEK, A JOHNSON & JOHNSON COMPANY
- 510(k) number
- K060830
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2006-06-15
- Date received
- 2006-03-27
- 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
- Ruth Forstadt
- Address
- 325 Paramount Dr. Raynham MA US 02767 02767
FDA Registration Numbers#
- 3016851379
- 3017209758
- 3008583793
- 3006791286
- 3016759112
- 3004154314
- 3007289093
- 8010379
- 3000203391
- 3014967149
- 3009941480
- 3004464325
- 3015718210
- 3013055499
- 9710312
- 2532027
- 3010097171
- 3007125392
- 3008812251
- 3005827567
- 3016727307
- 3004358587
- 3010032903
- 3007366790
- 3010560653
- 9617083
- 3010120104
- 3011015572
- 3022928161
- 3008870565
- 8010099
- 3004638532
- 3021008900
- 3014257776
- 3034525
- 3007113169
- 3014314623
- 3012470322
- 1221934
- 3004491689
- 3021226419
- 1225838
- 3020899789
- 3007441485
- 3011301313
- 3042508254
- 3015075784
- 3014104093
- 3010120148
- 2011171
- 1423662
- 3011656326
- 2133928
- 1036836
- 3009882675
- 3008747271
- 1043534
- 3010673777
- 3041501961
- 3003898228
- 3003236702
- 3006128100
- 1526711
- 3026586698
- 1319660
- 9681465
- 3009973699
- 3008791302
- 3009189869
- 2031093
- 2183650
- 3015183635
- 3013561205
- 3009132077
- 3008650117
- 9611813
- 9615021
- 3009201148
- 3010120339
Source Documents#
Other 510(k) Records For Product Code HWC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K260361 | Treace Medical Concepts (TMC) Screw Fixation System | Treace Medical Concepts, Inc. | 2026-03-06 |
| K252901 | Tyber Medical Trauma Screw | Tyber Medical, LLC | 2025-12-31 |
Legacy Summary#
summary
FDA Review#
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