ORCHID ORTHOPEDICS-CHELSEA

Registration Details

Registration Name: ORCHID ORTHOPEDICS-CHELSEA
Registration Number: 1827096
FEI Number: 1827096
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 13800 Luick Dr
City: Chelsea
State: MI
ZIP: 48118
Country: US

Owner / Operator

Firm Name: Orchid Orthopedic Solutions
Operator Number: 10042895
Address: 13800 Luick Drive
City: Chelsea
State: MI
Postal Code: 48118
Country: US
Correspondent: Albert A DeWalt

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	LZO	Class 2	Orthopedic	No	2024-04-02
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	LPH	Class 2	Orthopedic	No	2024-04-02
Impactor	HWA	Class 1	Orthopedic	No	2025-02-17
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	JDI	Class 2	Orthopedic	No	2026-04-30
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	JWH	Class 2	Orthopedic	No	2026-04-30
Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer	HSX	Class 2	Orthopedic	No	2020-06-16
Shoulder Prosthesis, Reverse Configuration	PHX	Class 2	Orthopedic	No	2018-01-31
Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	LWJ	Class 2	Orthopedic	No	2015-05-13
Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer	KRR	Class 2	Orthopedic	No	2017-09-01
Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer	HRY	Class 2	Orthopedic	No	2017-09-01
Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer	NPJ	Class 2	Orthopedic	No	2017-09-01
Orthopedic Manual Surgical Instrument	LXH	Class 1	Orthopedic	No	2013-01-31
Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer	MBH	Class 2	Orthopedic	No	2018-12-14
Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented	KWY	Class 2	Orthopedic	No	2026-04-30
Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented	KWT	Class 2	Orthopedic	No	2019-12-20
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented	KWS	Class 2	Orthopedic	No	2019-12-20
Template	HWT	Class 1	Orthopedic	No	2013-01-30
Instrument, Manual, Surgical, General Use	MDM	Class 1	General, Plastic Surgery	No	2013-01-31
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained	JWJ	Class 2	Orthopedic	No	2013-01-09

Proprietary Names

Pinnacle Trials ATTUNE FB INSERT IMPACTOR DISTAL CENTRALIZER W/FINS Tibial Screw Hole Plug SFP Journey Comprehensive Augment Mini Size Check 20 Deg Comprehensive Augment Mini Size Check 30 Deg Comprehensive Augment Mini Implant Provisional 10 Deg Comprehensive Augment Mini Size Check 10 Deg Comprehensive Augment Mini Reamer Guide Bushing Comprehensive Augment Mini Implant Provisional 20 Deg Comprehensive Augment Mini Implant Provisional 30 Deg I-Hip Restoris MCK Implant System Multiple Pivot Bipolar Liner Pivot Bipolar Retaining Ring BKSR Pull Tab SFP Augmented Glenoid Patello-Femoral Implant Augment Pull Tab Cement Restrictor SFP Attune Tibial Trial Triathlon Tibial Insert Size 0 Pinnacle Trial Liner PFC Sigma Trial ORTHOPEDIC IMPLANT TRIALING INSTRUMENT Triathlon MSI Tibial Trial Inserts Triathlon THK Tibial Insert Trial Universal2 Total Wrist Implant System Attune

Establishment Types

Manufacture Medical Device for Another Party (Contract Manufacturer)