510(k) K081813
- Device
- UNIVERSAL COMPRESSION FRACTURE REPAIR SYSTEM
- Applicant
- U.S. IMPLANT SOLUTIONS, LLC
- 510(k) number
- K081813
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-03-12
- Date received
- 2008-06-26
- 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
- SCOTT GARRETT
- Address
- 650 S. Central Ave. Suite 1000 Oviedo FL US 32765 32765
FDA Registration Numbers#
- 3010287687
- 3009153862
- 3003525643
- 3016851379
- 9615128
- 3013055499
- 3021008900
- 3008668801
- 2650143
- 3010158639
- 3006563559
- 3015876273
- 3014763043
- 3015882686
- 3010400367
- 3008114965
- 3004187715
- 3026311512
- 3001239363
- 3009158523
- 3005064037
- 3015877656
- 3009631939
- 2022435
- 3021632375
- 3013561205
- 2649614
- 3010120104
- 2249615
- 2953359
- 1000461041
- 2437731
- 3031261833
- 3042765769
- 3013014058
- 9617083
- 3009971621
- 3009532798
- 3006272282
- 3010273872
- 3009996260
- 3027760323
- 3012130008
- 1064017
- 3010120339
- 3014262693
- 3002806470
- 8043792
- 3010052483
- 3014680795
- 3005061536
- 1834331
- 3005290844
- 9613350
- 3009973505
- 1818910
- 3014302784
- 3021226419
- 2530808
- 3020584246
- 3010329663
- 9611112
- 3030271054
- 3012755988
- 3015946784
- 2183744
- 2320767
- 3009540749
- 3016050940
- 3010331645
- 1057946
- 1047843
- 3006128100
- 3007993775
- 3035785605
- 3027339877
- 1320894
- 3010202439
- 3009973699
- 3009144915
Source Documents#
Other 510(k) Records For Product Code HWC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| 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 |
| K254077 | OSSIOfiber® Threaded Trimmable Fixation Nail | OSSIO , Ltd. | 2026-05-01 |
Legacy Summary#
summary
FDA Review#
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