510(k) K063726
- Device
- PLC SUTURE ANCHOR
- Applicant
- SMITH & NEPHEW INC., ENDOSCOPY DIV.
- 510(k) number
- K063726
- Product code
- HRS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-03-06
- Date received
- 2006-12-15
- Regulation
- 888.3030
- Classification name
- Plate, 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
- 3010370500
- 3009196021
- 3030926959
- 3010303097
- 3011500362
- 3008396464
- 3010646402
- 9615766
- 3006791286
- 3015356625
- 3043026734
- 1528646
- 1835831
- 2011171
- 1834379
- 3002962587
- 3004976965
- 3012329552
- 3025603301
- 3005641619
- 1221051
- 3015806723
- 3011295718
- 3017565094
- 3009826895
- 3013561205
- 3003249380
- 3009882675
- 1833986
- 3013011598
- 3010120135
- 3015131017
- 2530808
- 3029933740
- 3005751028
- 3011127597
- 3012491394
- 3009662565
- 3032588003
- 3005290844
- 1417592
- 1643264
- 3008650117
- 9611813
- 9612277
- 1051526
- 3013820441
- 3009973505
- 3014315669
- 3015231789
- 3010846112
- 8010099
- 3009996260
- 3007345964
- 3008556682
- 1424263
- 3004513872
- 3010118938
- 3008102042
- 9616944
- 9710312
- 9615128
- 9710629
- 9611579
- 3036756245
- 3004187715
- 2032830
- 3010362364
- 3007051929
- 3008262715
- 3016438694
- 3008559295
- 3031240334
- 3016851379
- 3008285983
- 3004941535
- 1319660
- 1526711
- 3014273424
Source Documents#
Other 510(k) Records For Product Code HRS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K261611 | TDM Large Bone Plate and Screw System | Tdm Co., Ltd. | 2026-10-02 |
| K262649 | Alians Forearm | Newclip Technics | 2026-09-28 |
| K261892 | ProRib Fixation System | Costa Surgical, Inc. | 2026-09-23 |
| K262098 | EnHAnce PEEK Bunion System | Nvision Biomedical Technologies | 2026-09-18 |
| K262963 | TMC Implant Fixation System | Treace Medical Concepts, Inc. | 2026-09-15 |
| K261647 | Tempo Plating System; Ultra Compression Screw System | Pace Surgical | 2026-09-03 |
| K261830 | FRAXION 3.5 Plate System (Various - See Catalog);FRAXION 4.5 Plate System (Various - See Catalog);FRAXION Mini Plate System (Various - See Catalog);FRAXION Bone Screw System (Various - See Catalog) | Ortler Global Tibbi Gerecler Anonim Sirketi | 2026-08-28 |
| K262537 | Versalock Sterile Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-08-19 |
| K260277 | MIKRON TRAUMA BONE PLATE& SCREW SYSTEM | Mikron Makina San. ve Tic. Ltd. Sti. | 2026-08-13 |
| K261511 | Xpert Ankle | Newclip Technics | 2026-07-28 |
| K261406 | Versalock Proximal Tibial Plating System | GM Dos Reis Industria e Comercio Ltda. | 2026-07-21 |
| K262032 | TriMed Non-Spanning Wrist Fusion Plates (NSFL-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFR-STD);TriMed Non-Spanning Wrist Fusion Plates (NSFL-SHB );TriMed Non-Spanning Wrist Fusion Plates (NSFR-SHB ) | TriMed, Inc. | 2026-07-16 |
| K261191 | Alians Elbow S | Newclip Technics | 2026-07-08 |
| K261054 | RibPlate System | Stryker Leibinger GmbH & Co KG | 2026-07-01 |
| K261351 | SALGINA 2.5mm Distal Radius System | Bonebridge AG | 2026-06-26 |
Legacy Summary#
summary
FDA Review#
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