Synthes Spine Co.Lp
West Chester, PA, US
Synthes Spine Co.Lp appears in FDA device records in West Chester, PA. FDA records list 18 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 18
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 18 510(k) clearances for Synthes Spine Co.Lp between 2005 and 2012. The busiest year on record is 2006, with 4. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2005 | 2 |
| 2006 | 4 |
| 2007 | 4 |
| 2008 | 4 |
| 2011 | 3 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K121852 | SYNTHES ZERO-P VARIABLE ANGLE (VA) | OVE | Substantially Equivalent | |
| K112459 | SYNTHES ZERO-P | OVE | Substantially Equivalent | |
| K112068 | SYNTHES ZERO-P VARIABLE ANGLE (VA) | OVE | Substantially Equivalent | |
| K103320 | SYNTHES XRL | MQP | Substantially Equivalent | |
| K081568 | ANTEGRA-T | KWQ | Substantially Equivalent | |
| K080020 | ARCOFIX | KWQ | Substantially Equivalent | |
| K072981 | SYNTHES ZERO-P | OVE | Substantially Equivalent | |
| K072434 | SYNTHES OC FUSION AND SYNAPSE SYSTEMS | MNI | Substantially Equivalent | |
| K072253 | SYNFIX-LR SPACER | OVD | Substantially Equivalent | |
| K070573 | SYNAPSE SYSTEM | MNI | Substantially Equivalent | |
| K062083 | SYNFIX -LR | MQP | Substantially Equivalent | |
| K062933 | SYNTHES ORACLE SPACER | MQP | Substantially Equivalent | |
| K063158 | SYNTHES ANTEGRA SYSTEM | KWQ | Substantially Equivalent | |
| K053418 | SYNTHES OC FUSION SYSTEM | KWP | Substantially Equivalent | |
| K061891 | SYNEX II | MQP | Substantially Equivalent | |
| K053508 | SYNFIX-LR | MQP | Substantially Equivalent | |
| K052151 | SYNTHES PANGEA MONOAXIAL SYSTEM | NKB | Substantially Equivalent | |
| K050451 | SYNTHES VECTRA SYSTEM | KWQ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- MNIOrthosis, Spinal Pedicle Fixation
- MQPSpinal Vertebral Body Replacement Device
- NKBThoracolumbosacral Pedicle Screw System
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain