510(k) K080358
- Device
- PLLA, HA SCREW
- Applicant
- SMITH & NEPHEW INC., ENDOSCOPY DIV.
- 510(k) number
- K080358
- Product code
- HWC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-04-23
- Date received
- 2008-02-11
- 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
- DEANA BOUSHELL
- Address
- 150 Minuteman Rd. Andover MA US 01810 01810
FDA Registration Numbers#
- 3010057495
- 3017196117
- 3030926959
- 3010303097
- 3011500362
- 3008396464
- 3010646402
- 3013564228
- 3006791286
- 3015356625
- 3043026734
- 1835831
- 2011171
- 1834379
- 3002962587
- 3004976965
- 3012329552
- 3025603301
- 3000203391
- 3005641619
- 1221051
- 1219602
- 2936485
- 3015398319
- 3011295718
- 3017565094
- 3015806723
- 3009826895
- 3013561205
- 3003249380
- 3009882675
- 1833986
- 3013011598
- 3010120135
- 3015131017
- 3016669046
- 2530808
- 3029933740
- 3011127597
- 3012491394
- 3010887276
- 3032588003
- 3005290844
- 3015539532
- 1417592
- 1643264
- 3008650117
- 9611813
- 9612277
- 3022295665
- 3008132398
- 1051526
- 3015895045
- 3013820441
- 3009973505
- 3014315669
- 3011943495
- 3015231789
- 3010846112
- 8010099
- 3022472578
- 3009996260
- 3007345964
- 3004365956
- 1424263
- 3004513872
- 3015151147
- 3007766601
- 3010118938
- 3008102042
- 3009132077
- 3017210488
- 9616944
- 2530154
- 9710312
- 9615128
- 2648623
- 9710629
- 9611579
- 3036756245
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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