510(k) K233302
- Device
- OSSIOfiber® Compression Staple
- Applicant
- OSSIO , Ltd.
- 510(k) number
- K233302
- Product code
- MNU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2023-11-16
- Date received
- 2023-09-29
- Regulation
- 888.3030
- Classification name
- Staple, Absorbable
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Taly Lindner
- Address
- 8 Hatochen St. Caesarea IL 3079861 3079861
FDA Registration Numbers#
- 3015231789
- 3008729892
- 1061927
- 3010400367
- 1220246
- 1018470
- 3014004349
- 1048735
- 3010331645
- 3014554088
- 3016851379
- 1226183
- 3019269298
- 1017294