GUARDIAN-SG Inflatable Bone Expander System
FDA 510(k) K143006 · Bm Korea Co., Ltd.
510(k) numberK143006
Submission
- Device name
- GUARDIAN-SG Inflatable Bone Expander System
- Applicant
- Bm Korea Co., Ltd.
Gunpo-Si, KR - Received
- October 20, 2014
- Decision date
- January 16, 2015
- 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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| K143110 | GALAXY MIS Screw SystemNKB · Traditional | 06/24/2015SE |
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| K111820 | Synster Cervical Cage, Alif Cage, Plif Cage, Ptlif Cage, Tlif CageODP · Traditional | 03/14/2012SE |
| K111593 | Guardian Inflatable Bone Expander SystemNDN · Traditional | 11/18/2011SE |
Questions and answers
When was GUARDIAN-SG Inflatable Bone Expander System cleared by the FDA?
GUARDIAN-SG Inflatable Bone Expander System (K143006) received a 510(k) decision of Substantially Equivalent on January 16, 2015, 88 days after the submission was received.
What is the product code of K143006?
The FDA product code is NDN – Cement, Bone, Vertebroplasty, a Class II (moderate risk) device regulated under 21 CFR 888.3027.