Medical Device Manufacturer · IL , Caesarea

OSSIO , Ltd.

19 submissions · 19 cleared · Since 2019
19
Total
19
Cleared
0
Denied

OSSIO , Ltd. — FDA 510(k) Submissions

OSSIO , Ltd. has submitted 19 FDA 510(k) premarket notifications since 2019, of which 19 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Pin, Fixation, Smooth, Fastener, Fixation, Biodegradable, Soft Tissue, Screw, Fixation, Bone, Staple, Absorbable . Use the specialty filter in the sidebar to narrow results.

19 devices
1–19 of 19
OSSIOfiber? Suture Anchor
K254055 · MAI Fastener, Fixation,... · Orthopedic
Feb 2026 69d
OSSIOfiber? Interference Screw
K252022 · MAI Fastener, Fixation,... · Orthopedic
Aug 2025 50d
OSSIOfiber? Suture Anchor
K251309 · MAI Fastener, Fixation,... · Orthopedic
May 2025 29d
OSSIOfiber? Suture Anchor 2.5-3.5 mm
K243760 · MAI Fastener, Fixation,... · Orthopedic
Apr 2025 118d
OSSIOfiber? Compression Staple
K241932 · MNU Staple, Absorbable · Orthopedic
Aug 2024 58d
OSSIOfiber? Threaded Trimmable Fixation Nail
K241277 · HWC Screw, Fixation, Bone · Orthopedic
Jul 2024 58d
OSSIOfiber? Threaded Trimmable Fixation Nails
K233198 · HWC Screw, Fixation, Bone · Orthopedic
Mar 2024 162d
OSSIOfiber? Pin Product Family, OSSIOfiber? Compression Screw, OSSIOfiber? Trimmable Fixation Nail
K231272 · HTY Pin, Fixation, Smooth · Orthopedic
Dec 2023 213d
OSSIOfiber? Compression Staple
K233302 · MNU Staple, Absorbable · Orthopedic
Nov 2023 48d
OSSIOfiber? Cannulated Trimmable Fixation Nail
K230750 · HTY Pin, Fixation, Smooth · Orthopedic
Sep 2023 180d
OSSIOfiber Compression Screw, OSSIOfiber Compression Screw, 6.5mm
K221193 · HWC Screw, Fixation, Bone · Orthopedic
Dec 2022 242d
OSSIOfiber Suture Anchor
K213415 · MAI Fastener, Fixation,... · Orthopedic
Mar 2022 160d
OSSIOfiber? Staple
K212594 · MNU Staple, Absorbable · Orthopedic
Jan 2022 158d
OSSIOfiber Compression Screw, 3.5mm
K213596 · HWC Screw, Fixation, Bone · Orthopedic
Dec 2021 39d
OSSIOfiber Cannulated Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, OSSIOfiber Trimmable Fixation Nail, Cannulated Design
K203465 · HTY Pin, Fixation, Smooth · Orthopedic
Jan 2021 43d
OSSIOfiber? Hammertoe Fixation System/OSSIOfiber? Hammertoe Fixation Implant
K201803 · HTY Pin, Fixation, Smooth · Orthopedic
Oct 2020 108d
OSSIOfiber? Compression Screws
K193660 · HWC Screw, Fixation, Bone · Orthopedic
Jul 2020 213d
OSSIOfiber? Hammertoe Fixation System/OSSIOfiber? Hammertoe Fixation Implant
K190652 · HTY Pin, Fixation, Smooth · Orthopedic
Mar 2020 359d
OSSIO? Pin Product Family
K181180 · HTY Pin, Fixation, Smooth · Orthopedic
Jan 2019 253d
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