Apollo Knotless Suture Anchor
Maruho Medical
Maruho-Medical
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3010841252 | 3010841252 | Maruho Medical Inc. | 1 | N | 2020-04-25 | 200 Cobb Parkway N Building 200, Suite 210 Marietta GA US 30062 |
| 3015191037 | 3015191037 | MARUHO MEDICAL INC | 1 | N | 2020-04-25 | 8748 Technology Way Reno NV US 89523 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 253935 | 1425233898 | K160304 | OsteoBullet Compression Screw | HWC | 2016-04-29 |
| 253935 | 1028359787 | K160194 | StarFuse Interphalangeal Pin | HTY | 2016-04-26 |
| 253935 | 1861017622 | K152255 | BoneCam Suture Anchors | MBI | 2015-11-16 |
| 253935 | 1028098207 | K142230 | Apollo Suture Anchor System and Titan Screws | MBI | 2014-09-10 |
| 253935 | 1095930752 | K133036 | APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS | MBI | 2014-03-06 |
| 253935 | 1251385225 | ||||
| 253935 | 1424139739 | ||||
| 253935 | 1662645452 | ||||
| 253935 | 1881289012 | ||||
| 224888 | 1896138782 |
Product Codes Associated With Registrations#
PMN#
GUDID#
Disposable Punch, 6.5 mm - Disposable Punch, 6.5 mm Pouch
2022-09-15
ABS Med Distraction Pin - ABS Med Distraction Pin, 14MM Patient (Inner)
2023-08-29
Distraction Pin, 14MM pouch - Sharp Distraction Pin, 14MM pouch
2022-12-19
Distraction Pin, 12MM pouch - Sharp Distraction Pin, 12MM pouch
2022-12-19
Distraction Screw - Distraction Screw, 14MM Patient (Inner)
2023-01-26
Distraction Screw - Distraction Screw, 12MM Patient (Inner)
2023-01-26
Distraction Screw, 14MM pouch - Surgix Distraction Screw, 14MM pouch
2022-09-01
Distraction Screw, 12MM pouch - Surgix Distraction Screw, 12MM pouch
2022-09-01
Kopis Knotless Anchor - Kopis 6.5mm Knotless Anchor, Peek
2022-05-10
Kopis Knotless Anchor - Kopis 5.5mm Knotless Anchor, Peek
2022-05-10
Kopis Knotless Anchor - Kopis 4.5mm Knotless Anchor, Peek
2022-05-10
Galen Small Joint Anchor - Galen Small Joint Anchor 3.3mm x 10mm, Size 2, MO6 Needles, Peek
2022-05-10
Galen Small Joint Anchor - Galen Small Joint Anchor 2.9mm x 10mm, Size 2, MO6 Needles, Peek
2022-05-10
Tri-Gate Notched Disposable Cannula - 8.5 ID x 70mm Tri-Gate Notched Disposable Cannula Pouch
2022-05-10
Tri-Gate Disposable Cannula - 8.5 ID x 90mm Tri-Gate Disposable Cannula
2022-05-10
Tri-Gate Disposable Cannula - 7.5 ID x 90mm Tri-Gate Disposable Cannula
2022-05-10
Tri-Gate Disposable Cannula - 6.5 ID x 90mm Tri-Gate Disposable Cannula
2022-05-10
Tri-Gate Disposable Cannula - 8.5 ID x 70mm Tri-Gate Disposable Cannula
2022-05-10
Tri-Gate Disposable Cannula - 7.5 ID x 70mm Tri-Gate Disposable Cannula
2022-05-10
Tri-Gate Disposable Cannula - 6.5 ID x 70mm Tri-Gate Disposable Cannula
2022-05-10
Distraction Pin , 14MM Pouch - KateMar Distraction Pin , 14MM Pouch
2022-05-06
Distraction Pin , 12MM Pouch - KateMar Distraction Pin , 12MM Pouch
2022-05-06
Apollo - apollo® Knotless Suture Anchor, Titanium, 6.5mm x 15mm
2022-03-31
itto - Itto S+L shuttle and loop for use with itto CSP 20 in size 1 UHMWPE
2021-09-24
itto - Itto S+L shuttle and loop for use with itto CSP 2 in size 1 UHMWPE
2021-09-24
Apollo - Disposable Surgical Punch, 5.5mm
2021-04-07
Apollo - Disposable Surgical Punch, 4.5mm
2021-04-07
apollo - Disposable Tap, 6.5mm
2021-02-28
apollo - Disposable Tap, 5.5mm
2021-02-28
apollo - Disposable Tap, 4.5mm
2021-02-28