510(k) K033046
- Device
- SUBTALAR PEG IMPLANT
- Applicant
- NEXA ORTHOPEDICS, INC.
- 510(k) number
- K033046
- Product code
- MJW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-12-23
- Date received
- 2003-09-29
- Regulation
- 888.3040
- Classification name
- Prosthesis, Subtalar, Plug, Polymer
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- LOUISE M FOCHT
- Address
- 990 Park Center Dr., Suite H Vista CA US 92083 92083
FDA Registration Numbers#
- 3017191784
- 3013365802
- 3014207283
- 3003477135
- 1450662
Source Documents#
Other 510(k) Records For Product Code MJW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K922292 | LUNDEEN SUBTALAR PEG IMPLANT | Sgarlato Laboratories, Inc. | 1992-10-23 |
Legacy Summary#
summary
FDA Review#
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