OSTEOMED CRANIAL DISTRACTION SYSTEM
FDA 510(k) clearance K121304 · decided 2012-08-22
Clearance details
- K-number
- K121304
- Device name
- OSTEOMED CRANIAL DISTRACTION SYSTEM
- Applicant
- Osteomed
- Decision
- Substantially Equivalent
- Date received
- 2012-05-01
- Decision date
- 2012-08-22
- Days to decision
- 113 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
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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 SMARTFLEX CRANIAL SPRING DISTRACTOR (K123885) | Osteomed LP | 2013-06-03 |
Recalls involving this device
No recalls on record reference this clearance.