The following data is part of a premarket notification filed by Cayenne Medical, Inc with the FDA for Short Surelock All-suture Anchor, 1.4mm With (1) Size 0 Uhmwpe Suture With Needles, Short Surelock All-suture Anchor, 1.4mm With (1) Size 2-0 Uhmwpe Suture With Needles.
| Device ID | K143473 |
| 510k Number | K143473 |
| Device Name: | Short SureLock All-Suture Anchor, 1.4mm With (1) Size 0 UHMWPE Suture With Needles, Short SureLock All-Suture Anchor, 1.4mm With (1) Size 2-0 UHMWPE Suture With Needles |
| Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
| Applicant | CAYENNE MEDICAL, INC 16597 N. 92ND ST Scottsdale, AZ 85260 |
| Contact | Shima Hashemian |
| Correspondent | Shima Hashemian CAYENNE MEDICAL, INC 16597 N. 92ND ST Scottsdale, AZ 85260 |
| Product Code | MBI |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-05 |
| Decision Date | 2015-03-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M543CM961420 | K143473 | 000 |
| M543CM961400 | K143473 | 000 |