Gap Endo-Exo Medullary System
FDA 510(k) K160545 · Pega Medical, Inc.
510(k) numberK160545
Submission
- Device name
- Gap Endo-Exo Medullary System
- Applicant
- Pega Medical, Inc.
Laval, CA - Received
- February 26, 2016
- Decision date
- November 23, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- HSB – Rod, Fixation, Intramedullary And Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3020
- Specialty
- Orthopedic
- Implant
- Yes
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| 510(k) | Device | Decision |
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| K220190 | The GIRO Growth Modulation SystemOBT · Traditional | 10/24/2022SE |
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| K192710 | The Simple Locking Intramedullary (Slim) SystemHSB · Traditional | 06/24/2020SE |
| K170704 | The Locking Pediatric Osteotomy Plate (LolliPOP) SystemKTT · Traditional | 09/08/2017SE |
| K163003 | Y3 Proximal Femoral Plate SystemHRS · Traditional | 03/16/2017SE |
| K143355 | The Simple Locking IntraMedullary (SLIM) SystemHSB · Traditional | 07/10/2015SE |
| K131591 | Free Gliding Slipped Capital Femoral Epiphysis Screw (Scfe)HWC · Traditional | 11/27/2013SE |
| 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 Gap Endo-Exo Medullary System cleared by the FDA?
Gap Endo-Exo Medullary System (K160545) received a 510(k) decision of Substantially Equivalent on November 23, 2016, 271 days after the submission was received.
What is the product code of K160545?
The FDA product code is HSB – Rod, Fixation, Intramedullary And Accessories, a Class II (moderate risk) device regulated under 21 CFR 888.3020.