HOFFMAN UNIVERSAL FOOT SUPPORT
FDA 510(k) clearance K821252 · decided 1982-06-22
Clearance details
- K-number
- K821252
- Device name
- HOFFMAN UNIVERSAL FOOT SUPPORT
- Applicant
- Howmedica Corp.
- Decision
- Substantially Equivalent
- Date received
- 1982-04-30
- Decision date
- 1982-06-22
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- KQZ
- Device class
- 1
- Regulation number
- 888.5890
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Mchenry, IL, 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 |
|---|---|---|
| TECNOL BUCKS TRACTION W/HEEL PROTECTOR (K884132) | Technol, Inc. | 1988-10-11 |
| TECNOL SECURE-ALL PELVIC TRACTION BELT (K882640) | Tecnol New Jersey Wound Care, Inc. | 1988-07-27 |
| OVER DRAPE LEG HOLDER (K871900) | Avec Scientific Design Corp. | 1987-06-16 |
| T.E.D.(TM) TRACTION DEVICE (K871296) | The Kendal Co. | 1987-04-15 |
| MURPHY ADJUSTABLE SPLINT (K854270) | Comfortex, Inc. | 1985-12-09 |
| TPG 1000 (K831002) | Physical Diagnostics, Inc. | 1983-06-24 |
| UNIVERSAL BUCKS TRACTION (K823660) | Warm & Form, Orthopedic Materials | 1982-12-30 |
| UNIVERSAL BUCKS TRACTION (K823163) | Warm & Form, Orthopedic Materials | 1982-11-10 |
| BACKTRAC 90-90 TRACTION (K802869) | Backtrac | 1980-12-11 |
| SPLINT, HOAKE INFLATABLE AIR (K781754) | Depuy, Inc. | 1978-11-08 |
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 |