FDA 510(k)
FDA class 2
Substantially Equivalent
🇪🇸 Spain
MANDIBULAR BONE DISTRACTOR
K Number: K945674
·
Decision Jun 2, 1995
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
59
Applicant Total
373
Review Days
196
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- MANDIBULAR BONE DISTRACTOR
- K Number
- K945674
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.4760
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Howmedica Corp.
- Date Received
- November 18, 1994
- Decision Date
- June 2, 1995
- Product Code
- MQN
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MQN | External Mandibular Fixator And/Or Distractor | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MQN), ordered by most recent decision date.
KLS Martin IPS Distraction
FDA 510(k)
FDA Class 2
·Dental
DePuy Synthes Maxillofacial Portfolio - MR Conditional
FDA 510(k)
FDA Class 2
·Dental
Stryker Pediatric Mandibular Distractor 2
FDA 510(k)
FDA Class 2
·Dental
Craniomaxillofacial Distraction System (CMFD)
FDA 510(k)
FDA Class 2
·Dental
Internal Distraction - Sterile
FDA 510(k)
FDA Class 2
·Dental
Mandible External Fixator - MR Conditional
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Howmedica Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K983528 | MICRO DYNAMIC MESH | Dec 23, 1998 | Substantially Equivalent |
| K983404 | TYPE 3 FEMORAL COMPONENTS | Dec 22, 1998 | Substantially Equivalent |
| K980925 | DURATION II TIBIAL INSERTS-ETHYLENE OXIDE STERILIZATION | Dec 16, 1998 | Substantially Equivalent |
| K980926 | DURATION II ACETABULAR COMPONENTS-ETHYLENE OXIDE STERILIZATION | Dec 16, 1998 | Substantially Equivalent |
| K980632 | DURATION II TIBIAL INSERTS - GAS PLASMA STERILIZATION | Dec 11, 1998 | Substantially Equivalent |
| K980626 | DURATION II ACETABULAR COMPONENTS-GAS PLASMA STERILIZATION | Dec 11, 1998 | Substantially Equivalent |
| K983419 | HOFFMANN II MIAMI POST | Nov 25, 1998 | Substantially Equivalent |
| K982958 | ZETA MULTIZONE LOCKING NAIL SYSTEM | Nov 20, 1998 | Substantially Equivalent |
| K982873 | ZETA MULTIZONE SCN LOCKING NAIL | Oct 21, 1998 | Substantially Equivalent |
| K982531 | HOWMEDICA LEIBINGER RESORBABLE FIXATION SYSTEM | Oct 16, 1998 | Substantially Equivalent |