Guardian Inflatable Bone Expander System
FDA 510(k) K111593 · Bm Korea Co., Ltd.
510(k) numberK111593
Submission
- Device name
- Guardian Inflatable Bone Expander System
- Applicant
- Bm Korea Co., Ltd.
Marietta, GA, US - Received
- June 7, 2011
- Decision date
- November 18, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NDN – Cement, Bone, Vertebroplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3027
- Specialty
- Orthopedic
- Implant
- Yes
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| 510(k) | Device | Decision |
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| K143110 | GALAXY MIS Screw SystemNKB · Traditional | 06/24/2015SE |
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| K122518 | Synster (Cervical,Alif, Plif, Ptlif and Tlif) Cage Hera Cervical Cage Rhea Plif Cage…ODP · Special | 02/15/2013SE |
| K120353 | Synster Pedicle Screw System Synster Plus Pedicle Screw SystemMNH · Traditional | 05/09/2012SE |
| K111820 | Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageODP · Traditional | 03/14/2012SE |
Questions and answers
When was Guardian Inflatable Bone Expander System cleared by the FDA?
Guardian Inflatable Bone Expander System (K111593) received a 510(k) decision of Substantially Equivalent on November 18, 2011, 164 days after the submission was received.
What is the product code of K111593?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.