Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop Anc
FDA 510(k) clearance K150209 · decided 2015-10-06
Clearance details
- K-number
- K150209
- Device name
- Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAnchor Plus Dual Suture, PanaLok RC QuickAnchor Plus w/Orthocord; PanaLok RC QuickAnchor Plus Dual Suture w/Orthocord, PanaLok Loop Anchor, Lupine Loop Anchor, PanaLok RC Lop Anchor, BioKnotless Anchor, BioKnotless RC Anchor, RC Loop Anc
- Applicant
- Depuy Mitek, A Johnson and Johnson Company
- Decision
- Substantially Equivalent
- Date received
- 2015-01-30
- Decision date
- 2015-10-06
- Days to decision
- 249 days
- Clearance type
- Traditional
- Product code
- MAI
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Raynham, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DePuy Mitek BIOKNOTLESS Plus w/ Ethibond-Iindicated for use in soft tissue to bone fixatio recall (Z-1677-2023) | DePuy Mitek, Inc., a Johnson & Johnson Co. | 2023-06-02 |
| DePuy Mitek BIOKNOTLESS Plus w/ Panacryl-Indicated for use in soft tissue to bone fixation recall (Z-1678-2023) | DePuy Mitek, Inc., a Johnson & Johnson Co. | 2023-06-02 |
| DePuy Mitek BIOKNOTLESS Plus w/ OC-Indicated for use in soft tissue to bone fixation in as recall (Z-1679-2023) | DePuy Mitek, Inc., a Johnson & Johnson Co. | 2023-06-02 |
| DePuy Mitek BIOKNOTLESS Rapid W/ OC-Indicated for use in soft tissue to bone fixation in a recall (Z-1680-2023) | DePuy Mitek, Inc., a Johnson & Johnson Co. | 2023-06-02 |
| DePuy Mitek BIOKNOTLESS Rapid w/ Pan-Indicated for use in soft tissue to bone fixation in recall (Z-1681-2023) | DePuy Mitek, Inc., a Johnson & Johnson Co. | 2023-06-02 |