STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS
FDA 510(k) clearance K071157 · decided 2007-09-17
Clearance details
- K-number
- K071157
- Device name
- STRYKER PEEK AND TITANIUM SOFT EYELET ANCHORS
- Applicant
- Stryker Endoscopy
- Decision
- Substantially Equivalent
- Date received
- 2007-04-25
- Decision date
- 2007-09-17
- Days to decision
- 145 days
- Clearance type
- Traditional
- Product code
- HWC
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Stryker Titanium Intraline Anchor, Model Numbers 3910400050, 3910400055, 3910400060, 39104 recall (Z-0618-2011) | Stryker Endoscopy | 2010-12-14 |
| Stryker Peek Intraline Anchor, 5.5 mm, Model number 3910-400-010 Used for tissue fixation recall (Z-1533-2008) | Stryker Endoscopy | 2008-08-06 |
| Stryker Peek Intraline Anchor, 5.5 mm with Needles, Model number 3910-400-015 Used for tis recall (Z-1534-2008) | Stryker Endoscopy | 2008-08-06 |
| Stryker Peek Intraline Anchor, 6.5 mm, Model number 3910-400-020 Used for tissue fixation recall (Z-1535-2008) | Stryker Endoscopy | 2008-08-06 |
| Stryker Peek Intraline Anchor, 6.5 mm with Needles, Model number 3910-400-025 Used for tis recall (Z-1536-2008) | Stryker Endoscopy | 2008-08-06 |