510(k) K922292
- Device
- LUNDEEN SUBTALAR PEG IMPLANT
- Applicant
- SGARLATO LABORATORIES, INC.
- 510(k) number
- K922292
- Product code
- MJW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-10-23
- Date received
- 1992-05-15
- Regulation
- 888.3040
- Classification name
- Prosthesis, Subtalar, Plug, Polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- THOMAS E SGARLATO
- Address
- 100 O'Connor Dr., Suite 18 San Jose CA US 95128 95128
FDA Registration Numbers#
- 3017191784
- 3013365802
- 3014207283
- 3003477135
- 1450662
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code MJW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K033046 | SUBTALAR PEG IMPLANT | Nexa Orthopedics, Inc. | 2003-12-23 |
Legacy Summary#
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FDA Review#
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