Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003595343

FEI Number

3003595343

Entity Name

Vaupell Midwest Molding and Tooling

City/State/Country

Constantine, MI, US

Establishment Address

485 Florence Rd, Constantine, MI 49042, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Vaupell Molding and Tooling, Inc. (Owner Number: 10042966)

Owner / Operator Contact Address

485 Florence Road, Constantine, MI 49042, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Silhouette Instalift SMS28 Silhouette Instalift SMS31 Silhouette Instalift SMS29 Silhouette Instalift SMS30 Silhouette Soft Suture SMS26 Silhouette Soft Suture SMS25 Silhouette Soft Suture SMS23 Silhouette Soft Suture SMS22 Silhouette Soft Suture SMS102 Lower Trauma Instruments

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LZO	Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented	Orthopedic	Class 2	888.3353	2013-03-05
LWJ	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented	Orthopedic	Class 2	888.3360	2013-03-05
KWZ	Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer	Orthopedic	Class 2	888.3310	2013-03-05
JDL	Prosthesis, Hip, Semi-Constrained (Metal Cemented Acetabular Component)	Orthopedic	Class 3	888.3320	2013-03-05
LPH	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented	Orthopedic	Class 2	888.3358	2013-03-05
JDI	Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented	Orthopedic	Class 2	888.3350	2013-03-05
KWA	Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)	Orthopedic	Class 3	888.3330	2013-03-05
NQP	Posterior Metal/Polymer Spinal System, Fusion	Orthopedic	Class 2	888.3070	2013-03-05
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2022-02-11
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2022-02-11
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2021-11-08
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2014-11-11
JCX	Apparatus, Suction, Ward Use, Portable, Ac-Powered	General, Plastic Surgery	Class 2	878.4780	2014-11-11
HBB	Motor, Drill, Pneumatic	Neurology	Class 2	882.4370	2013-01-15
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2020-03-10
GAW	Suture, Nonabsorbable, Synthetic, Polypropylene	General, Plastic Surgery	Class 2	878.5010	2020-03-10
GAM	Suture, Absorbable, Synthetic, Polyglycolic Acid	General, Plastic Surgery	Class 2	878.4493	2020-03-10
FYD	Apparatus, Exhaust, Surgical	General, Plastic Surgery	Class 2	878.5070	2013-01-15

Official Correspondent

Leslie Balyeat

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Vaupell Molding and Tooling, Inc.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K030151	Hayes Medical, Inc.	CONSENSUS HIP SYSTEM, UNISYN HIP SYSTEM	2003-04-10
K153381	Corin U.S.A. Limited	Corin Metafix Hip Stem	2016-01-21
K140975	Lima Corporate S.P.A.	MASTERSL FEMORAL STEM	2014-06-10
K932222	Dow Corning Wright	SLT FEMORAL HEAD	1994-05-27
K910547	Turnkey Intergration USA, Inc.	FELDMUEHLE CERAMIC HEAD (12/14 X 28MM)	1991-04-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0012-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" P-12 Cutting, Product Number: SV426, UDI: 20884521151731 - 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-0013-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 0 Undyed 36" KV-34 TaperCutting, Product Number: CV919, UDI: 20884521151649 - 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-0014-2021	Riverpoint Medical, LLC	2	Velosorb Fast Braided Absorbable Suture: Covidien Velosorb 4/0 Undyed 30" C-12 Cutting, Product Number: SV2294, UDI 20884521151403 - 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 3003595343. Last updated year: 2026. Please use registration number 3003595343 when referencing this establishment in official correspondence.