Data / Medical devices / United States / Kinamed, Inc.
Kinamed, Inc.: FDA-registered device maker in Camarillo, CA, United States, 8 510(k) clearances
Kinamed, Inc. is registered with the FDA (registration 2027148) in Camarillo, CA, United States. It lists 13 device types. The FDA files 8 510(k) clearances under its listings, the newest dated August 1, 2018. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2027148
- Address
- 820 Flynn Rd, Camarillo, CA, United States, 93012
- Owner or operator
- VME ACQUISITION CORP. (2020352)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 31, 2008
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | 2 | Manufacturer | accessdata.fda.gov |
| Caliper | KTZ | 1 | Manufacturer | accessdata.fda.gov |
| Cerclage, Fixation | JDQ | 2 | Manufacturer | accessdata.fda.gov |
| Cover, Burr Hole | GXR | 2 | Manufacturer | accessdata.fda.gov |
| Fastener, Plate, Cranioplasty | HBW | 2 | Manufacturer | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Contract manufacturer | accessdata.fda.gov |
| Lavage, Jet | FQH | 2 | Manufacturer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer | accessdata.fda.gov |
| Plate, Cranioplasty, Preformed, Alterable | GWO | 2 | Manufacturer | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | 2 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Manufacturer | accessdata.fda.gov |
| Screw, Fixation, Intraosseous | DZL | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 1, 2018 | K181749 | SuperCable® Iso-Elastic Cerclage System | JDQ | Substantially Equivalent | Kinamed, Incorporated | accessdata.fda.gov |
| April 5, 2013 | K122049 | NEUROPRO LOW PROFILE CRANIAL PLATING SYSTEM | GWO | Substantially Equivalent | Kinamed, Inc. | accessdata.fda.gov |
| November 9, 2007 | K072250 | SUPERCABLE GRIP AND PLATE SYSTEM | KTT | Substantially Equivalent | Kinamed, Inc. | accessdata.fda.gov |
| October 21, 2003 | K030256 | ISO-ELASTIC CERCLAGE SYSTEM | JDQ | Substantially Equivalent | Kinamed, Inc. | accessdata.fda.gov |
| May 21, 2002 | K013982 | KINEMATCH PATELLO-FEMORAL RESURFACING IMPALANT | KRR | Substantially Equivalent | Kinamed, Inc. | accessdata.fda.gov |
| September 8, 1998 | K982927 | QUICK TAP SELF DRILLING SCREW | DZL | Substantially Equivalent | Kinamed, Inc. | accessdata.fda.gov |
| January 16, 1997 | K964362 | KINAMED PROFIX SYSTEM | HRS | Substantially Equivalent | Kinamed, Inc. | accessdata.fda.gov |
| June 11, 1993 | K926337 | BONE LAVAGE SYSTEM | FQH | Substantially Equivalent | Innovative Surgical Devices Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 18, 2010 | 58808 | Not yet classified | Terminated | Kinamed SuperCable Grip and Plate System Driver, 3.5mm Hex, Catalog Number: 35-860-2060 The driver is intended to be used in conjunction with compression and locking bone screws for fixation of long bone fractures when K | The recall was initiated due to inadequate mechanical strength of these screwdrivers' hexagonal tip feature, causing it to strip during final tightening. | accessdata.fda.gov |
Compare with other makers
- All makers of Plate, Fixation, Bone
- All makers of Instrument, Manual, Surgical, General Use
- All makers of Plate, Cranioplasty, Preformed, Alterable
- All makers of Cover, Burr Hole
- All makers of Fastener, Plate, Cranioplasty
- All makers of Cerclage, Fixation
Updated August 1, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.