ANSPACH KNOTLESS ANCHOR
FDA 510(k) clearance K052572 · decided 2005-12-05
Clearance details
- K-number
- K052572
- Device name
- ANSPACH KNOTLESS ANCHOR
- Applicant
- The Anspach Effort, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-09-19
- Decision date
- 2005-12-05
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Palm Beach Gardens, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is inten recall (Z-1875-2014) | The Anspach Effort, Inc. | 2014-06-25 |
| ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool with recall (Z-1876-2014) | The Anspach Effort, Inc. | 2014-06-25 |
| ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is intended to be u recall (Z-1915-2014) | The Anspach Effort, Inc. | 2014-06-25 |
| ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device recall (Z-1916-2014) | The Anspach Effort, Inc. | 2014-06-25 |