CONNEXX LOCKING TIBIA NAIL
FDA 510(k) clearance K080706 · decided 2008-06-09
Clearance details
- K-number
- K080706
- Device name
- CONNEXX LOCKING TIBIA NAIL
- Applicant
- I.T.S. Implantat-Technologie-Systeme GmbH
- Decision
- Substantially Equivalent
- Date received
- 2008-03-12
- Decision date
- 2008-06-09
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- JDS
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Prior Lake, MN, US
- Third-party review
- No
- Expedited review
- No
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| WIN Flexible Nail System (K193533) | Biomet, Inc. | 2020-02-20 |
| CONVENTUS PHS SYSTEM (K141737) | Conventus Orthopaedics, Inc. | 2015-04-08 |
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| SYNTHES SUPRAPATELLAR INSERTION INSTRUMENTS (K111667) | Synthes (Usa) | 2011-12-05 |
| SYNTHES (USA) PEDIATRIC LCP HIP PLATE SYSTEM MODIFICATIONS (K072095) | Synthes (Usa) | 2007-09-27 |
Recalls involving this device
No recalls on record reference this clearance.