LUNDEEN SUBTALAR PEG IMPLANT
FDA 510(k) clearance K922292 · decided 1992-10-23
Clearance details
- K-number
- K922292
- Device name
- LUNDEEN SUBTALAR PEG IMPLANT
- Applicant
- Sgarlato Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-05-15
- Decision date
- 1992-10-23
- Days to decision
- 161 days
- Clearance type
- Traditional
- Product code
- MJW
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Jose, 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 |
|---|---|---|
| SUBTALAR PEG IMPLANT (K033046) | Nexa Orthopedics, Inc. | 2003-12-23 |
Recalls involving this device
No recalls on record reference this clearance.