GOUFFON PIN, ADJUSTABLE
FDA 510(k) clearance K760454 · decided 1976-08-26
Clearance details
- K-number
- K760454
- Device name
- GOUFFON PIN, ADJUSTABLE
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1976-08-16
- Decision date
- 1976-08-26
- Days to decision
- 10 days
- Clearance type
- Traditional
- Product code
- JDW
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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| Steinmann Pins and Kirschner Wires (K211508) | Stryker GmbH | 2021-10-05 |
| Extended HA Half Pins (K210784) | Smith & Nephew, Inc. | 2021-04-02 |
| Syntec Non-Sterile Steinmann Pins System (K200933) | Syntec Scientific Corporation | 2020-05-05 |
| Orthopedic Fixation Pin (K191803) | Tinavi (Anhui) Medical Technologies Co., Ltd. | 2020-04-14 |
| Temporary Fixation Pins (K192768) | Eisertech, LLC | 2019-12-26 |
| SMV Scientific K-Wire and Pins (K182171) | Summit Medventures | 2018-10-25 |
| Ultima HA Coated Half Pins and Wire (K163487) | Vilex IN Tennessee, Inc. | 2017-02-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| SURGICAL SIMPLEX P BONE CEMENT (N17004/S013) | Howmedica Corp. | 2000-12-15 |
| SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT (N17004/S012) | Howmedica Corp. | 2000-06-20 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S011) | Howmedica Corp. | 1998-03-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S010) | Howmedica Corp. | 1997-11-13 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S009) | Howmedica Corp. | 1997-08-08 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S008) | Howmedica Corp. | 1996-12-18 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S005) | Howmedica Corp. | 1995-11-21 |
| SURGICAL SIMPLEX(R) P RADIOPAQUE BONE CEMENT (N17004/S006) | Howmedica Corp. | 1995-02-24 |