OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR
FDA 510(k) clearance K123885 · decided 2013-06-03
Clearance details
- K-number
- K123885
- Device name
- OSTEOMED SMARTFLEX CRANIAL SPRING DISTRACTOR
- Applicant
- Osteomed LP
- Decision
- Substantially Equivalent
- Date received
- 2012-12-18
- Decision date
- 2013-06-03
- Days to decision
- 167 days
- Clearance type
- Traditional
- Product code
- PBJ
- Device class
- 2
- Regulation number
- 882.5330
- Medical specialty
- Neurology
- Advisory committee
- Neurology
- Location
- Addison, TX, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Osteomed LP
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| CranioXpand (K230211) | KLS-Martin L.P. | 2023-11-21 |
| Craniomaxillofacial Distraction System (CMFD) (K170818) | Synthes USA Products, LLC | 2017-12-07 |
| Internal Distraction - Sterile (K163315) | KLS Martin L.P. | 2017-05-05 |
| RxG Distraction System (K150771) | KLS Martin L.P. | 2015-08-27 |
| OSTEOMED CRANIAL DISTRACTION SYSTEM (K121304) | Osteomed | 2012-08-22 |
Recalls involving this device
No recalls on record reference this clearance.