Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe)
FDA 510(k) K131591 · Pega Medical, Inc.
510(k) numberK131591
Submission
- Device name
- Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe)
- Applicant
- Pega Medical, Inc.
Laval, CA - Received
- May 31, 2013
- Decision date
- November 27, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HWC – Screw, Fixation, Bone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3040
- Specialty
- Orthopedic
- Implant
- Yes
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| K261241 | TriMed Compression ScrewsHWC · Special | TriMed, Inc. | 05/14/2026SE |
| K254215 | Arthrex Beaming SystemHWC · Traditional | Arthrex, Inc. | 05/08/2026SE |
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| K170704 | The Locking Pediatric Osteotomy Plate (LolliPOP) SystemKTT · Traditional | 09/08/2017SE |
| K163003 | Y3 Proximal Femoral Plate SystemHRS · Traditional | 03/16/2017SE |
| K160545 | Gap Endo-Exo Medullary SystemHSB · Traditional | 11/23/2016SE |
| K143355 | The Simple Locking IntraMedullary (SLIM) SystemHSB · Traditional | 07/10/2015SE |
| K111232 | Gap Endo-Exo Medullary SystemHSB · Traditional | 01/26/2012SE |
| K090440 | Hinge Pediatric Plating SystemHRS · Traditional | 05/20/2009SE |
| K041393 | Fassier-Duval Telscopic Im SystemHSB · Traditional | 08/17/2004SE |
Questions and answers
When was Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe) cleared by the FDA?
Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe) (K131591) received a 510(k) decision of Substantially Equivalent on November 27, 2013, 180 days after the submission was received.
What is the product code of K131591?
The FDA product code is HWC – Screw, Fixation, Bone, a Class II (moderate risk) device regulated under 21 CFR 888.3040.