510(k) K133906
- Device
- C-JAWS CERVICAL COMPRESSIVE STAPLE
- Applicant
- MEDICREA INTERNATIONAL
- 510(k) number
- K133906
- Product code
- PHQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2014-07-24
- Date received
- 2013-12-23
- Regulation
- 888.3060
- Classification name
- Anterior Staple As Supplemental Fixation For Fusion
- Medical specialty
- Orthopedic
- Review panel
- Orthopedic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN J SMITH
- Address
- 555 Thirteenth St. NW Washington DC US 20004 20004
FDA Registration Numbers#
- 3036756245
- 3033509898
- 3006272282
- 2032098
- 3025603301
- 1649518
Source Documents#
Other 510(k) Records For Product Code PHQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K200301 | UNiTi ACDF Implant System | Pressio, Inc. | 2021-02-03 |
Legacy Summary#
summary
FDA Review#
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