Orthomet, Inc.
Plymouth, MN, US
Orthomet, Inc. appears in FDA device records in Plymouth, MN. FDA records list 60 510(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
- 60
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 60FDA records hold 60 510(k) clearances for Orthomet, Inc. between 1986 and 1995. The busiest year on record is 1988, with 13. The most recent is 1995, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1986 | 3 |
| 1987 | 3 |
| 1988 | 13 |
| 1989 | 7 |
| 1990 | 5 |
| 1991 | 4 |
| 1992 | 9 |
| 1993 | 5 |
| 1994 | 8 |
| 1995 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K936310 | ORTHOMET HMC FEMORAL STEM COMPONENT | LPH | Substantially Equivalent | |
| K945783 | ORTHOMET TITANIUM HYBRID FEMORAL STEM | JDG | Substantially Equivalent | |
| K943873 | ORTHOMET ANATOMICALLY GUIDED CARPAL TUNNEL RELEASE SY | LXH | Substantially Equivalent | |
| K944752 | ORTHOMET RESURFACING FEMORAL COMPONENT | KXA | Substantially Equivalent | |
| K930771 | PERFECTA TOTAL HIP SYSTEM COATED COCR FEMORAL STEM | JDI | Substantially Equivalent for Some Indications | |
| K926334 | AXIOM TOTAL KNEE SYST/ACL RETAIN TIBIAL TRAY/INSER | JWH | Substantially Equivalent for Some Indications | |
| K932677 | AXIOM TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | |
| K931678 | ORTHOMET LHMC FEMORAL STEM | HMC | Substantially Equivalent | |
| K931333 | ORTHOMET ACETABULAR CUP SYSTEM | LPH | Substantially Equivalent | |
| K925536 | HYBRID FEMORAL STEM, PERFECTA TOTAL HIP SYSTEM | KWY | Substantially Equivalent for Some Indications | |
| K923243 | PERFECTA TOTAL HIP SYSTEM | JDI | Substantially Equivalent | |
| K924698 | AXIOM TOTAL KNEE SYSTEM, MODULAR TIBIAL TRAY | JWH | Substantially Equivalent | |
| K930595 | AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB TRAY | JWH | Substantially Equivalent for Some Indications | |
| K924050 | TITANIUM NITRIDE COATED HEMI-HEAD COMPONENT | KWL | Substantially Equivalent | |
| K922847 | PERFECTA TOTAL HIP SYSTEM | JDI | Substantially Equivalent | |
| K922733 | PERFECTA TOTAL HIP SYSTEM AND PROFORMA TOTAL HIP | JDI | Substantially Equivalent | |
| K915190 | PERFECTA TOTAL HIP SYSTEM, HA COATED | MEH | Substantially Equivalent | |
| K923583 | ORTHOMET PERFECTA TOTAL HIP SYSTEM | LZO | Substantially Equivalent for Some Indications | |
| K921836 | PERFECTA TOTAL HIP SYSTEM, CERAMIC FEMORAL HEAD | LZO | Substantially Equivalent | |
| K923909 | CEMENT RESTRICTOR FOR PROFORMA AND PERFECTA TOTAL | LZN | Substantially Equivalent | |
| K922734 | AXIOM TOTAL KNEE SYSTEM AND PLUS TOTAL KNEE SYSTEM | JWH | Substantially Equivalent for Some Indications | |
| K920698 | FEMORAL AND ALL POLY TIBIAL TRAY COMPONENTS | JWH | Substantially Equivalent | |
| K920426 | PSK FEMORAL AND TIBIAL INSERT COMPONENT | JWH | Substantially Equivalent | |
| K915868 | PERFECTA TOTAL HIP SYSTEM, HEMI-HEAD COMPONENT | KWL | Substantially Equivalent | |
| K915795 | PERFECTA PDA TOTAL HIP SYSTEM | JDI | Substantially Equivalent | |
| K914230 | AXIOM TOTAL KNEE SYSTEM, ALL POLY TIBIAL TRAY | JWH | Substantially Equivalent for Some Indications | |
| K912894 | AXIOM TOTAL KNEE SYSTEM, A/P CURVED TIBIAL INSERT | JWH | Substantially Equivalent | |
| K911198 | TIBIAL TRAY PMMA PLUG FOR PLUS/AXIOM TOTAL KNEE SY | JWH | Substantially Equivalent | |
| K911197 | PLUS TOTAL KNEE SYST/AXIOM TOTAL KNEE SYSTEM | JWH | Substantially Equivalent | |
| K903635 | PERFECTA TOTAL HIP SYSTEM | JDI | Substantially Equivalent | |
| K895145 | SECOND GENERATION KNEE SYSTEM, FEMORAL, PATELLAR | JWH | Substantially Equivalent for Some Indications | |
| K901936 | PLUS TOTAL KNEE SYST/PERI POST DESIGN TIBIAL COMP | JWH | Substantially Equivalent for Some Indications | |
| K902259 | AXIOM TOTAL KNEE SYSTEM, TIBIAL COMPONENT | JWX | Substantially Equivalent for Some Indications | |
| K901328 | DOMED AND FINNED ACETABULAR COMPONENT | JDI | Substantially Equivalent for Some Indications | |
| K893040 | ORTHOMET PLUS TOTAL KNEE SYST, TITANIUM TIBIAL PEG | JWH | Substantially Equivalent | |
| K894334 | SECOND GENERATION KNEE SYSTEM | JWH | Substantially Equivalent for Some Indications | |
| K893762 | PLUS TOTAL KNEE SYSTEM, (PPD) TIBIAL COMPONENT | JWH | Substantially Equivalent for Some Indications | |
| K892398 | BIPOLAR HIP SYSTEM | KXA | Substantially Equivalent | |
| K890742 | INTRAFORM TOTAL HIP SYSTEM | JDI | Substantially Equivalent for Some Indications | |
| K884027 | PERFECTA II/NON-COATED TOTAL HIP SYSTEM | JDI | Substantially Equivalent | |
| K884585 | LEA PLAZA SPINAL FRAME SYSTEM | KWP | Substantially Equivalent | |
| K883618 | PERFECTA II TOTAL HIP SYSTEM | JDI | Substantially Equivalent for Some Indications | |
| K883941 | PROFORMA HIP SYSTEM | JDI | Substantially Equivalent | |
| K880435 | PROFORMA/PS TOTAL HIP SYSTEM | JDI | Substantially Equivalent | |
| K880390 | INTRAFORM TOTAL HIP SYSTEM | JDI | Substantially Equivalent | |
| K880461 | PERFECTA TOTAL HIP SYSTEM | JDI | Substantially Equivalent for Some Indications | |
| K880004 | TOWNLEY COX COMB ACETABULAR CUP | JDI | Substantially Equivalent | |
| K875201 | PLUS TOTAL KNEE SYSTEM, POLY TIBIAL PEG | JWH | Substantially Equivalent for Some Indications | |
| K874914 | ORTHOMET ORTHOPEDIC STAPLES | JDR | Substantially Equivalent | |
| K874915 | ORTHOMET CATHCART ORTHOCENTRIC HIP PROSTHESIS | KWL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- LZNCement Obturator
- JDQCerclage, Fixation
- JWXKit, Screening, Staphylococcus Aureus
- HMCMonitor, Eye Movement, Diagnostic
- LXHOrthopedic Manual Surgical Instrument
- HTYPin, Fixation, Smooth
- HRSPlate, Fixation, Bone
- JDGProsthesis, Hip, Femoral Component, Cemented, Metal
- KXAProsthesis, Hip, Femoral, Resurfacing
- KWLProsthesis, Hip, Hemi-, Femoral, Metal
- KWYProsthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented
- LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
- JDIProsthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate
- JWHProsthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- HWCScrew, Fixation, Bone
- JDRStaple, Fixation, Bone
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain