The following data is part of a premarket notification filed by Medshape Solutions with the FDA for Shapeloc-cl (cruciate Ligament) Soft Tissie Fastner, Shapeloc-st (tenodesis) Soft Tissue Fastner.
| Device ID | K101808 |
| 510k Number | K101808 |
| Device Name: | SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER |
| Classification | Screw, Fixation, Bone |
| Applicant | MEDSHAPE SOLUTIONS 1575 NORTHSIDE DR. SUITE 440 Atlanta, GA 30318 |
| Contact | Jack Griffs |
| Correspondent | Jack Griffs MEDSHAPE SOLUTIONS 1575 NORTHSIDE DR. SUITE 440 Atlanta, GA 30318 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-29 |
| Decision Date | 2010-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M970110001082006 | K101808 | 000 |
| 20653405986840 | K101808 | 000 |
| 20653405986857 | K101808 | 000 |
| M970110001062004 | K101808 | 000 |
| M970110001072005 | K101808 | 000 |
| M970110001092007 | K101808 | 000 |
| M970110100073006 | K101808 | 000 |
| M970110100083007 | K101808 | 000 |
| M970110100093008 | K101808 | 000 |
| M970110000062800 | K101808 | 000 |
| M970110000073005 | K101808 | 000 |
| M970110000083006 | K101808 | 000 |
| M970110000093007 | K101808 | 000 |
| 20653405986833 | K101808 | 000 |