The following data is part of a premarket notification filed by Medshape, Inc with the FDA for Helical Ridge Peek Interference Screw.
| Device ID | K141290 |
| 510k Number | K141290 |
| Device Name: | HELICAL RIDGE PEEK INTERFERENCE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | MEDSHAPE, INC 1575 NORTHSIDE DRIVE NW SUITE 440 Atlanta, GA 30318 |
| Contact | Jack Griffis |
| Correspondent | Jack Griffis MEDSHAPE, INC 1575 NORTHSIDE DRIVE NW 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 | 2014-05-19 |
| Decision Date | 2014-09-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M970140020047500 | K141290 | 000 |
| M970140017047500 | K141290 | 000 |
| M970140015047500 | K141290 | 000 |