Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015183635

FEI Number

3015183635

Entity Name

Nypro Healthcare Baja Inc. (Albuquerque)

City/State/Country

Albuquerque, NM, US

Establishment Address

3801 University Blvd, SE, Albuquerque, NM 87106, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Jabil Inc. (Owner Number: 9074019)

Owner / Operator Contact Address

10800 Roosevelt Blvd., Saint Petersburg, FL 33716, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Accessories Arthroscopic Instruments, Suture Graspers EIT Cellular Titanium LLIF Cages REAMER (MULTIPLE BRANDS) PROFILE ECHELON LINEAR 60 mm Cutter (GLC60) ECHELON LINEAR Cutters 80mm Green ECHELON LINEAR Cutters 60mm Green Reload (GLCR60G) ECHELON LINEAR Cutters 80mm Blue Reload (GLCR80B) ECHELON LINEAR 100 mm Cutter (GLC100) ECHELON LINEAR 80mm Cutter (GLC80) ECHELON LINEAR Cutters 60mm Blue Reload (GLCR60B) ACL Graft Knives EIT Cellular Titanium Cervical Cage EIT Cellular Titanium ALIF Cages EIT Cellular Titanium TLIF Cages EIT Cellular Titanium LLIF Cages EIT Cellular Titanium T/PLIF Cages Manual Orthopedic Instruments Instrument surgical instrument ORTHOPEDIC MANUAL SURGICAL INSTRUMENT CHIA PERCPASSER, DePuy Mitek Instrument TROCHANTERIC FIXATION NAIL (TFN) Latarjet ECHELON FLEXTM Powered Plus Articulating Endoscopic Linear cutters Rigidloop Disposable Kit ETHICON 3D Reload HINDFOOT ARTHRODESIS NAIL GII Harmonic® 1100 Shears ETHICON 3D Reload Ethicon Circular Stapler Ethicon Circular Stapler, XL Sealed SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEM GII LIGACLIP MCA ETHICON Linx Esophagus Sizing Tool Echelon Contour Curved Cutter with reloads

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2018-08-15
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-04-05
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
HTO	Reamer	Orthopedic	Class 1	888.4540	2019-03-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-15
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2019-03-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-03-04
DXT	Injector And Syringe, Angiographic	Cardiovascular	Class 2	870.1650	2019-07-24
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2023-06-19
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2023-06-19
FFP	Dilator, Rectal	Gastroenterology, Urology	Class 1	876.5450	2019-02-18
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2019-03-04
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-03-04
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2023-08-15
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-03-06
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2019-03-04
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2023-01-10
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2019-02-25
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2023-01-10
MZM	Fibrin Sealant Preparation Device	General Hospital	Class 2	880.5860	2019-03-26
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-03-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-03-04
KDC	Instrument, Surgical, Disposable	General, Plastic Surgery	Class 1	878.4800	2019-03-08
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-03-23
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
ODP	Intervertebral Fusion Device With Bone Graft, Cervical	Orthopedic	Class 2	888.3080	2022-04-05
MAX	Intervertebral Fusion Device With Bone Graft, Lumbar	Orthopedic	Class 2	888.3080	2022-04-05
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-03-04
JOL	Catheter And Tip, Suction	General Hospital	Class 2	880.6740	2019-03-08
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2019-03-06
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-03-06
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2015-01-15
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2019-02-25
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-03-04
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2019-03-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-03-04
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2019-02-25
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-03-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2019-03-08
HWC	Screw, Fixation, Bone	Orthopedic	Class 2	888.3040	2023-08-15
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-10-22
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-03-04
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2019-03-04
KDD	Kit, Surgical Instrument, Disposable	General, Plastic Surgery	Class 1	878.4800	2023-08-15
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2025-05-28
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-03-25
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-03-08
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-03-08
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2019-03-06
HTO	Reamer	Orthopedic	Class 1	888.4540	2019-05-02
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2019-05-02
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2019-05-01
HTO	Reamer	Orthopedic	Class 1	888.4540	2019-05-01
OCW	Endoscopic Tissue Approximation Device	Gastroenterology, Urology	Class 2	876.1500	2019-02-25
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-08-15
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2020-09-01
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-09-01
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2020-09-01
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2019-02-25
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
FMF	Syringe, Piston	General Hospital	Class 2	880.5860	2019-03-06
HIF	Insufflator, Laparoscopic	Obstetrics/Gynecology	Class 2	884.1730	2019-03-06
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2024-10-30
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-03-04
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2021-02-26
GEA	Cannula, Surgical, General & Plastic Surgery	General, Plastic Surgery	Class 1	878.4800	2019-03-04
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2019-03-04
HTO	Reamer	Orthopedic	Class 1	888.4540	2020-12-02
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2020-12-02
JDR	Staple, Fixation, Bone	Orthopedic	Class 2	888.3030	2023-08-15
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2019-03-23
FOD	Device, Occlusion, Umbilical	General Hospital	Class 1	880.5950	2019-03-08
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-03-04
FDP	Apparatus, Pneumoperitoneum, Automatic	Gastroenterology, Urology	Class 2	876.1500	2019-03-06
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2019-03-06
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2019-03-06
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2019-03-06
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2019-03-06
KTT	Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component	Orthopedic	Class 2	888.3030	2019-03-08
HSB	Rod, Fixation, Intramedullary And Accessories	Orthopedic	Class 2	888.3020	2019-03-08
GBX	Catheter, Irrigation	General, Plastic Surgery	Class 1	878.4200	2019-03-08
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2019-03-25
GDT	Staple, Removable (Skin)	General, Plastic Surgery	Class 1	878.4760	2019-02-18
GAG	Stapler, Surgical	General Hospital	Class 2	878.4740	2019-02-25
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
FZP	Clip, Implantable	General, Plastic Surgery	Class 2	878.4300	2026-03-20
QJN	Laparoscopic Accessories, Esophageal Sizing	Gastroenterology, Urology	Class 2	876.5360	2020-12-04
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2019-03-06
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2020-10-22
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-03-04
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2019-03-23
GDW	Staple, Implantable	General, Plastic Surgery	Class 2	878.4750	2019-02-25
HGI	Electrocautery, Gynecologic (And Accessories)	Obstetrics/Gynecology	Class 2	884.4120	2020-06-16
LFL	Instrument, Ultrasonic Surgical	Unknown	Class U	N/A	2020-06-16
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-06-16

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Jabil Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3015410662	Jabil Inc. (Wilson Drive)	W Chester, PA, US
3011246727	Jabil Circuit Sdn. Bhd.	Bayan Lepas Pulau Pinang, MY
3003512059	NYPRO DR, LLC (Bldg 11)	Haina San Cristobal, DO
3004730544	NYPRO DR, LLC (Building 52)	Haina San Cristobal, DO
1424235	Nypro Inc. (Chicago)	GURNEE, IL, US

Related 510(k) Records

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K223430	Life Spine, Inc.	ProLift Micro Expandable Spacer System	2023-05-04
K102293	Globus Medical, Inc.	CALIBER SPACER	2011-01-05
K193541	Nu Vasive, Incorporated	NuVasive Cohere Thoracolumbar Interbody System	2020-03-30
K080401	Advanced Medical Technologies AG	SHELL CAGE, WAVE CAGE, LOOP CAGE	2008-05-09
K200084	Zavation Medical Products, LLC	Zavation IBF System	2020-10-19

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0040-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 3mm Offset (Blue) Catalog Number: 72201713 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0041-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 4mm Offset (Purple Catalog Number: 72201714 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0042-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 5mm Offset (Red) Catalog Number: 72201715 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0043-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 6mm Offset (Green) Catalog Number: 72201716 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.
Z-0044-2011	Smith & Nephew, Inc. Endoscopy Division	1	Smith & Nephew Aimer Endofemoral 7mm Offset (Gold) Catalog Number: 72201717 ACUFEX Surgical Instruments are intended for use in orthopedic and general surgery.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015183635. Last updated year: 2026. Please use registration number 3015183635 when referencing this establishment in official correspondence.