Stryker PEEK and Titanium Soft Eyelet Anchors
FDA 510(k) K071157 · Stryker Endoscopy
510(k) numberK071157
Submission
- Device name
- Stryker PEEK and Titanium Soft Eyelet Anchors
- Applicant
- Stryker Endoscopy
San Jose, CA, US - Received
- April 25, 2007
- Decision date
- September 17, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261057 | ActivaScrew Cannulated COMHWC · Traditional | Bioretec, Ltd. | 09/04/2026SE |
| K260106 | OsteoCoil GT Active Compression SystemHWC · Traditional | Flower Orthopedics Corporation DBA Conventus… | 08/24/2026SE |
| K262344 | Large Compression ScrewsHWC · Special | TriMed, Inc. | 08/12/2026SE |
| K253858 | GFS - Sterile Screws and Top HatHWC · Special | T.A.G. Medical Products Corporation, Ltd. | 08/05/2026SE |
| K262075 | Lapidus Screw KitHWC · Special | Relja Innovations, LLC | 07/22/2026SE |
| K260809 | Arthrex Sterile VAL and VAL KreuLock Compression Screw SystemHWC · Traditional | Arthrex, Inc. | 06/25/2026SE |
| K253108 | VEOFIX Snap Off ScrewHWC · Traditional | Steps Ortho | 06/05/2026SE |
| K261154 | CoLink® & CoLag® Non-Sterile ScrewsHWC · Special | In2Bones USA, LLC | 05/30/2026SE |
| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
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| 510(k) | Device | Decision |
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| K253602 | Precision S 4K SinuscopeGWG · Traditional | 06/04/2026SE |
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| K260185 | 1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with…GCJ · Special | 02/18/2026SE |
| K260108 | L12 LED Light Source with AIMOWN · Special | 02/12/2026SE |
| K254014 | Connected OR Hub with Device and Voice Control; SDC4K Information Management System with…GCJ · Special | 01/13/2026SE |
| K253888 | MOLLI 2 SystemNEU · Special | 12/31/2025SE |
| K252010 | SPY LaparoscopeGCJ · Special | 07/24/2025SE |
| K252012 | SPY Cystoscope/HysteroscopeHIH · Special | 07/18/2025SE |
| K250544 | Knotilus+ Biocomposite Knotless AnchorMAI · Traditional | 05/23/2025SE |
Questions and answers
When was Stryker PEEK and Titanium Soft Eyelet Anchors cleared by the FDA?
Stryker PEEK and Titanium Soft Eyelet Anchors (K071157) received a 510(k) decision of Substantially Equivalent on September 17, 2007, 145 days after the submission was received.
What is the product code of K071157?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.