Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010692967

FEI Number

3010692967

Entity Name

Surgical Specialties Mexico S DE RL DE CV

City/State/Country

Tijuana Baja California, MX

Establishment Address

Corredor Tijuana - Rosarito 2000-24702 B, Ejido Francisco Villa, Tijuana Baja California 22235, MX

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Corza Medical Inc (Owner Number: 9060279)

Owner / Operator Contact Address

2755 Canyon Boulevard 1st Floor, Boulder, CO 80302, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Instratek Quill Stratafix Spiral Polypropylene Knotless Tissue Control Device Quill Polypropylene Knotless Tissue-Closure Device Stylus Edge Tec 6S Vision Sharpoint Focus UniqueEdge Sharpoint" Plus Sharpoint Monoderm Absorbable Suture Instratek Ultra Plug Ultra Plug Collagen Implant Instratek Sharpoint B. G. Sulzle Sharpoint FSSB Medline Surgical Specialties Sharpoint - Lukens Sharpoint Quill Quill PDO Knotless Tissue-Closure Device Stratafix Spiral PDO Knotless Tissue Control Device Stylus Sharpoint UniqueEdge Sharpoint Microsurgical Blades Unique Edge 6S Vision LOOK Gut Sutures (Plain and Chromic) Sharpoint Plus Express Gut Sharpoint Sharpoint Gut Sutures (Plain and Chromic) Sharpoint" Plus (Plain and Chromic) Look Silk Sutures Sharpoint Silk Sutures Sharpoint" Plus Sharpoint QUILL Quill Monoderm Knotless Tissue-Closure Device Stratafix Spiral PGA-PCL Knotless Tissue Control Device Quill Quill Monoderm Knotless Tissue-Closure Device Sharpoint UniqueEdge Arthrex® Tightrope Sharpoint B. G. Sulzle Stratafix Spiral PDO Knotless Tissue Control Device Quill Quill PDO Knotless Tissue-Closure Device UltraPlug Silicone Punctal Plugs Ultra Plug Surgical Specialties Sharpoint Quill Quill Monoderm Knotless Tissue-Closure Device Stratafix Spiral PGA-PCL Knotless Tissue Control Device Sharpoint LOOK Sharpoint Plus Quill Look Sharpoint LOOK Sharpoint Plus Sharpoint" Plus Sharpoint Quill QUILL Stratafix Spiral PGA-PCL Knotless Tissue Control Device Quill Monoderm Knotless Tissue-Control Device Quill UltraPlug Ultra Plug PCL Punctum Plugs LOOK Sharpoint Flow Controller LOOK Stratafix Spiral Knotless Tissue Control Device Quill Monoderm Knotless Tissue-Closure Device Quill Sharpoint MSP Stylus Sharpoint SULZLE DRILLED-END NEEDLES Stratafix Spiral PDO Knotless Tissue Control Device QUILL Quill PDO Knotless Tissue-Closure Device Look Nylon Suture Sharpoint Sharpoint Nylon Suture Sharpoint" Plus Stratafix Spiral Polypropylene Knotless Tissue Control Device Quill Polypropylene Knotless Tissue-Closure Device QUILL QUILL PPN Stratafix Spiral PDO Knotless Tissue Control Device Quill Quill PDO Knotless Tissue-Closure Device Quill PDO Knotless Tissue-Closure Device Stratafix Spiral PDO Knotless Tissue Control Device

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2017-08-02
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2015-07-15
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2016-02-01
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2009-03-12
NBH	Accessories, Arthroscopic	Orthopedic	Class 1	888.1100	2017-08-02
LZU	Plug, Punctum	Unknown	Class U	N/A	2009-03-12
HRX	Arthroscope	Orthopedic	Class 2	888.1100	2017-08-02
KBR	Needle, Tonsil Suturing	Ear, Nose, Throat	Class 1	874.4420	1992-12-31
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2022-02-02
MTJ	Wax, Bone	Unknown	Class U	N/A	2009-04-08
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2015-07-16
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	2008-09-25
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2009-04-09
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2009-04-09
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2015-07-15
LZU	Plug, Punctum	Unknown	Class U	N/A	2024-02-26
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2015-07-16
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2016-02-19
HNN	Knife, Ophthalmic	Ophthalmic	Class 1	886.4350	1992-12-31
MBI	Fastener, Fixation, Nondegradable, Soft Tissue	Orthopedic	Class 2	888.3040	2025-04-08
GDL	Needle, Suturing, Reusable	General, Plastic Surgery	Class 1	878.4800	1992-12-31
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2015-07-15
LZU	Plug, Punctum	Unknown	Class U	N/A	2008-09-25
MTJ	Wax, Bone	Unknown	Class U	N/A	2015-05-28
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2008-09-25
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2015-05-06
GAT	Suture, Nonabsorbable, Synthetic, Polyethylene	General, Plastic Surgery	Class 2	878.5000	2015-05-06
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2015-05-06
GAQ	Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	General, Plastic Surgery	Class 2	878.4495	2015-05-06
GAL	Suture, Absorbable, Natural	General, Plastic Surgery	Class 2	878.4830	2015-05-06
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2014-08-13
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2008-09-25
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2018-08-10
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2015-03-08
LZU	Plug, Punctum	Unknown	Class U	N/A	2008-09-25
GAP	Suture, Nonabsorbable, Silk	General, Plastic Surgery	Class 2	878.5030	2015-09-10
LZU	Plug, Punctum	Unknown	Class U	N/A	2024-02-26
NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	General, Plastic Surgery	Class 2	878.5035	2016-08-22
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2015-07-15
EMF	Knife, Surgical	General, Plastic Surgery	Class 1	878.4800	1992-12-31
GAB	Needle, Suturing, Disposable	General, Plastic Surgery	Class 1	878.4800	1992-06-26
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2015-07-15
GAR	Suture, Nonabsorbable, Synthetic, Polyamide	General, Plastic Surgery	Class 2	878.5020	2009-03-30
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	1992-12-31
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2024-02-26
GEJ	Carrier, Ligature	General, Plastic Surgery	Class 1	878.4800	2024-02-26
NBY	Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene	General, Plastic Surgery	Class 2	878.5035	2024-02-26
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2024-02-26
NEW	Suture, Surgical, Absorbable, Polydioxanone	General, Plastic Surgery	Class 2	878.4840	2015-03-08
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2022-12-13

Official Correspondent

Alex Castillo

US Agent Details

Alex Castillo Email: RegulatoryAffairs@corza.com Phone: (619) 6178100

Related Public Records

Same Entity

Corza Medical 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
3011767135	SSC- Surgical Specialties Corporation	Chula Vista, CA, US
3007109793	Surgical Specialties Corporation Limited (UK)	Taunton Somerset, GB

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K081051	Spine View, Inc.	SPINEVU ENDOSCOPIC SPINE SYSTEM (SESS), SPINEVU MINISCOPE	2008-08-07
K820777	The Anspach Effort, Inc.	MINI-MICRO ARTHROSCOPIC SCAPEL	1982-05-12
K123940	Demetech Corp.	DEMEQUICKTM (RAPID ABSORBABLE) SYNTHETIC SURGICAL SUTURE	2014-05-30
K050845	ETHICON, Inc.	MONOCRYL PLUS ANTIBACTERIAL SUTURE	2005-06-29
K874057	Myocure, Inc.	OPHTHALMIC TIP & BLADE SCALPELS	1987-12-23

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0041-05	Linvatec Corp.	2	Ultra Power Burs, Sterile, Single-Use.
Z-0012-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Carbon Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0013-2008	Becton Dickinson & Company	1	Shelf Pack: Bard-Parker Rib-Back Stainless Steel no.11, surgical blade. Unit Package: Contents of unopened or undamaged package guaranteed sterile; After use place product in a puncture resistant container and dispose properly. Becton Dickinson Becton Dickinson Acute Care Franklin Lakes, NJ 07417
Z-0010-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 6/0 Undyed 18" P-10 Cutting, Product Number: SV9913, UDI: 20884521153278 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.
Z-0011-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 3/0 Undyed 30" P-14 Cutting, Product Number: SV935, UDI: 20884521151755 - Product Usage: indicated for use in soft tissue approximation of the skin and mucosa, where only 7-10 days of wound support is required, but not for use in ligation, ophthalmic, cardiovascular or neurological procedures.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010692967. Last updated year: 2026. Please use registration number 3010692967 when referencing this establishment in official correspondence.