GRAVITY™ Syndesmosis LP
FDA 510(k) clearance K170249 · decided 2017-06-30
Clearance details
- K-number
- K170249
- Device name
- GRAVITY™ Syndesmosis LP
- Applicant
- Wrightmedicaltechnologyinc
- Decision
- Substantially Equivalent
- Date received
- 2017-01-27
- Decision date
- 2017-06-30
- Days to decision
- 154 days
- Clearance type
- Traditional
- Product code
- HTN
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Memphis, TN, US
- Third-party review
- No
- Expedited review
- No
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| LARS ACJ (K253115) | Movmedix S.A.S. | 2026-06-10 |
| SportLinc Syndesmosis Device (K252081) | Lincotek Medical | 2026-03-27 |
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| RipCord (K251134) | TriMed, Inc. | 2025-07-11 |
| Acu-Sinch Knotless Mini (K243624) | Acumed, LLC | 2025-01-23 |
| Bolo Button System (K242091) | Fusion Orthopedics | 2024-12-23 |
| TACTIX Vector Syndesmosis System (K243408) | Vilex, LLC | 2024-11-27 |
| EXPERT - Flexible Joint Fixation System (K242311) | GM Dos Reis Industria e Comercio Ltda. | 2024-11-01 |
| TACTIX Vector Syndesmosis System (K240035) | Vilex, LLC | 2024-08-01 |
| TENSOR® Suture Button System (K240947) | Globus Medical, Inc. | 2024-06-03 |
| OIC FLEX-FIX™ System (K233531) | Orthopaedic Implant Company | 2024-02-02 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ADCON(R)-L ADHESION CONTROL IN A BARRIER GEL (P960057/S011) | Wrightmedicaltechnologyinc | 2000-09-27 |
| ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S004) | Wrightmedicaltechnologyinc | 1999-08-11 |
| ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S008) | Wrightmedicaltechnologyinc | 1999-06-02 |
| ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S006) | Wrightmedicaltechnologyinc | 1999-04-21 |
| ADCON-L ADHESION CONTROL IN A BARRIER GEL (P960057/S005) | Wrightmedicaltechnologyinc | 1999-03-18 |
| ADCON -L ADHESION CONTROL IN A BARRIER GEL (P960057/S003) | Wrightmedicaltechnologyinc | 1999-01-14 |
| ADCON -L ADHESION CONTROL IN A BARRIER GEL (P960057/S002) | Wrightmedicaltechnologyinc | 1998-11-25 |
| ADCON-L ANTI-ADHESION CONTROL IN A BARRIER GEL (P960057/S001) | Wrightmedicaltechnologyinc | 1998-09-11 |