Data / Medical devices / United States / Eagle Medical Packaging Sterilization, Inc.
Eagle Medical Packaging Sterilization, Inc.: FDA-registered device maker in Paso Robles, CA, United States, 49 510(k) clearances
Eagle Medical Packaging Sterilization, Inc. is registered with the FDA (registration 2028632) in Paso Robles, CA, United States. It lists 39 device types. The FDA files 49 510(k) clearances under its listings, the newest dated April 27, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2028632
- FEI number
- 1000125025
- Address
- 2921 Union RD, Paso Robles, CA, United States, 93446
- Owner or operator
- EAGLE MEDICAL, INC. (9005849)
- Roles
- Contract manufacturer, Contract sterilizer, Repackager or relabeler
- First device listed
- December 20, 2012
- Registered through
- 2026
- Brand names listed
- AcuTie Sternal System, Acumed 3.5mm Extremity Screw, Acumed Anatomic Radial Head System, Acumed Bone Graft System, Acumed Bone Plate System, Acumed Cannulated Cancellous Bone Screw, Acumed Cerclage Crimp Sleeve, Acumed Congruent Bone Plate System and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| April 27, 2022 | K220892 | ExsoMed INnate NanoTM Lag Screw System | HWC | Substantially Equivalent | Exsomed Corp. | accessdata.fda.gov |
| December 21, 2021 | K213456 | Xenco Medical Multilevel CerviKit | KWQ | Substantially Equivalent | Xenco Medical, LLC | accessdata.fda.gov |
| July 1, 2019 | K190166 | TriMed Nitinol Staple System | JDR | Substantially Equivalent | TriMed, Inc. | accessdata.fda.gov |
| March 6, 2019 | K183397 | ChoiceSpine Stealth Cervical Spacer System | ODP | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| May 16, 2018 | K180519 | HARRIER-SA Lumbar Interbody System | OVD | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| January 26, 2018 | K172816 | TiGer Shark System | MAX | Substantially Equivalent | Choicespine, LP | accessdata.fda.gov |
| October 21, 2016 | K160313 | Xenco Medical Cervical Interbody System | OVE | Substantially Equivalent | Xenco Medical, LLC | accessdata.fda.gov |
| September 6, 2016 | K161478 | Xenco Medical Posterior Cervical System | NKG | Substantially Equivalent | Xenco Medical, LLC | accessdata.fda.gov |
| July 1, 2016 | K160604 | Cure Anterior Cervical Plate (ACP) System | KWQ | Substantially Equivalent | Meditech Spine, LLC | accessdata.fda.gov |
| June 29, 2016 | K152501 | Spinal Jaxx Interbody Fusion Device | MAX | Substantially Equivalent | Neuropro Spinaljaxx, Inc. | accessdata.fda.gov |
| May 4, 2016 | K160986 | Xenco Medical Pedicle Screw System | NKB | Substantially Equivalent | Xenco Medical, LLC | accessdata.fda.gov |
| February 23, 2016 | K160198 | UreTron MultiProbe Lithotripter System | FFK | Substantially Equivalent | Med-Sonics Corp. | accessdata.fda.gov |
| May 28, 2015 | K150130 | Ascendant TM Cervical Spacer System | ODP | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| May 11, 2015 | K150152 | The Octane Straight Intervertebral Fusion Device, Ti Coated | MAX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| March 20, 2015 | K143158 | Xenco Medical Lumbar Interbody System | MAX | Substantially Equivalent | Xenco Medical, LLC | accessdata.fda.gov |
| August 15, 2014 | K141129 | EXACTECH CERVICAL SPACER SYSTEM | ODP | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| May 1, 2013 | K130434 | OCTANE STRAIGHT, OCTANE STRAIGHT - LORDOTIC, OCTANE STRAIGHT I/R, OCTANE STRAIGHT I/R - LORDOTIC | MAX | Substantially Equivalent | Exactech, Inc. | accessdata.fda.gov |
| April 24, 2012 | K112734 | APLAN A.V. FISTULA NEEDLE SET | FIE | Substantially Equivalent | Aplan Well Enterprise Co., Ltd. | accessdata.fda.gov |
| August 29, 2011 | K111608 | SLIC SCREW REPAIR SYSTEM | HWC | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| January 4, 2011 | K102998 | CONGRUENT BONE PLATE SYSTEM | HRS | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| June 30, 2010 | K090803 | HANSON MEDICAL FACIAL IMPLANTS | FZE | Substantially Equivalent | Hanson Medical, Inc. | accessdata.fda.gov |
| July 15, 2009 | K090707 | TALOS INTERVERTEBRAL BODY FUSION DEVICE | MAX | Substantially Equivalent | Meditech Advisors, LLC | accessdata.fda.gov |
| January 13, 2009 | K083167 | PHENIX CERVICAL INTERBODY DEVICE | ODP | Substantially Equivalent | Spinal Devices, LLC | accessdata.fda.gov |
| September 16, 2008 | K082270 | OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM | MAX | Substantially Equivalent | Vertiflex, Inc. | accessdata.fda.gov |
| May 12, 2005 | K051083 | ACUMED SCAPULA CONGRUENT BONE PLATE SYSTEM | HRS | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| October 5, 2004 | K041858 | ACUMED ANATOMIC RADIAL HEAD SYSTEM | KWI | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| January 15, 2004 | K033639 | ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM | HWC | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| July 17, 2003 | K031438 | ACUMED SMALL BONE LOCKING ROD SYSTEM II | HSB | Substantially Equivalent | Acumed, LLC | accessdata.fda.gov |
| July 17, 2002 | K021321 | WRIST FUSION PLATE | HRS | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| December 19, 2001 | K013616 | POLARUS CAP SCREW | HSB | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| November 7, 2001 | K012655 | CONGRUENT BONE PLATE SYSTEM | HRS | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| February 4, 2000 | K992525 | ACUMED MODULAR SHOULDER SYSTEM | HSD | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| February 19, 1997 | K965029 | STABLELOC II EXTERNAL FIXATOR | JEC | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| December 9, 1996 | K964500 | ACUMED TENSION BAND PIN | HTY | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| May 7, 1996 | K960711 | ACUMED BONE GRAFT SYSTEM | KIJ | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| October 5, 1995 | K952330 | EXTERNAL FIXATOR | JEC | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| May 5, 1995 | K944330 | ACUTRAK PLUS FIXATION SYSTEM | HWC | Substantially Equivalent for Some Indications | Acu Med, Inc. | accessdata.fda.gov |
| April 13, 1995 | K942359 | BONE PLATE SYSTEM | HRS | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| January 27, 1995 | K943857 | EXTERNAL FIXATOR | JEC | Substantially Equivalent for Some Indications | Acu Med, Inc. | accessdata.fda.gov |
| December 5, 1994 | K942341 | CANNULATED CANCELLOUS BONE SCREW | HWC | Substantially Equivalent for Some Indications | Acu Med, Inc. | accessdata.fda.gov |
| December 5, 1994 | K942340 | CORTICAL BONE SCREW | HWC | Substantially Equivalent for Some Indications | Acu Med, Inc. | accessdata.fda.gov |
| November 9, 1994 | K942603 | ORTHOPAEDIC WIRES | LRN | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| February 22, 1994 | K933361 | ACUMED RADIUS ROD | HSB | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| February 22, 1994 | K931246 | CERCLAGE WIRE CRIMP SLEEVE | JDQ | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| February 15, 1994 | K931244 | BONE PLATE | HRS | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| July 26, 1993 | K930834 | ACUTRACT | HWC | Substantially Equivalent | Acu Med, Inc. | accessdata.fda.gov |
| June 26, 1992 | K921480 | OSTEO-CLAGE(TM) CERCIAGE CABLE SYSTEM | JDQ | Substantially Equivalent | Acu-Med, Inc. | accessdata.fda.gov |
| February 13, 1992 | K915613 | BONE SCREW 3.5 MM | HWC | Substantially Equivalent for Some Indications | Acu Med, Inc. | accessdata.fda.gov |
| July 28, 1982 | K821801 | NORSEN DEBRIDER | GED | Substantially Equivalent | Bel-Med, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Plate, Fixation, Bone
- All makers of Screw, Fixation, Bone
- All makers of Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment
- All makers of Cerclage, Fixation
- All makers of Intervertebral Fusion Device With Bone Graft, Lumbar
- All makers of Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Updated April 27, 2022. 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.