SUTTER HAMMERTOE JOINT PROSTHESIS
FDA 510(k) clearance K943354 · decided 1995-06-12
Clearance details
- K-number
- K943354
- Device name
- SUTTER HAMMERTOE JOINT PROSTHESIS
- Applicant
- Sutter Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-07-12
- Decision date
- 1995-06-12
- Days to decision
- 335 days
- Clearance type
- Traditional
- Product code
- KWH
- Device class
- 2
- Regulation number
- 888.3720
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Diego, CA, 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 |
|---|---|---|
| NewPrim System (K191966) | Brm Extremities | 2020-02-13 |
| Fusion Silastic System (K190136) | Fusion Orthopedics, LLC | 2019-10-21 |
| RTS Lesser MTP Implant System (K173491) | In2bones USA, LLC | 2018-02-23 |
| RTS Flexible 1 MPJ Implant w/Grommets (K153609) | In2bones USA, LLC | 2016-09-08 |
| ORTHOFLEX ROD (K102601) | Ortho-Pro, LLC | 2011-01-14 |
| LESSER METATARSAL PHALANGEAL JOINT IMPLANT (K023531) | Nexa Orthopedics, Inc. | 2003-01-17 |
| INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM (K022887) | Osteomed Corp. | 2002-11-26 |
| METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM (K022886) | Osteomed Corp. | 2002-11-25 |
| MODIFICATION TO CLASSIC GREAT TOE IMPLANT (K023562) | Nexa Orthopedics, Inc. | 2002-11-13 |
| CLASSIC GREAT TOE IMPLANT (K023086) | Nexa Orthopedics, Inc. | 2002-10-04 |
| ASCENT KNEE SYSTEM (K994326) | Biomet Manufacturing, Inc. | 2000-01-07 |
| FUTURA BIOMEDICAL FLEXIBLE GREAT TOE IMPLANT (K981194) | Nexa Orthopedics, Inc. | 1998-06-30 |
Recalls involving this device
No recalls on record reference this clearance.