The following data is part of a premarket notification filed by Acumed Llc with the FDA for Acu-sinch Repair System And Acumed Suture Anchor.
| Device ID | K112111 |
| 510k Number | K112111 |
| Device Name: | ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR |
| Classification | Washer, Bolt Nut |
| Applicant | ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro, OR 97124 -9432 |
| Contact | Lino Tsai |
| Correspondent | Lino Tsai ACUMED LLC 5885 NW CORNELIUS PASS RD. Hillsboro, OR 97124 -9432 |
| Product Code | HTN |
| Subsequent Product Code | HRS |
| Subsequent Product Code | HWC |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-07-25 |
| Decision Date | 2011-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10806378095085 | K112111 | 000 |
| 10806378095078 | K112111 | 000 |
| 10806378092909 | K112111 | 000 |
| 10806378091001 | K112111 | 000 |
| 10806378090998 | K112111 | 000 |
| 10806378045349 | K112111 | 000 |
| 10806378029547 | K112111 | 000 |