Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1825527

FEI Number

1825527

Entity Name

SURGICAL TECHNOLOGY LABORATORIES INC.

City/State/Country

Lugoff, SC, US

Establishment Address

1566 Whiting Way, Lugoff, SC 29078, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SURGICAL TECHNOLOGY LABORATORIES INC. (Owner Number: 1825527)

Owner / Operator Contact Address

1566 Whiting Way, --, Lugoff, SC 29078, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K983756

PMA Number

N/A

All Registered Proprietary Names

SurgiPlast PureForm SFAM SFAM 3-D Surgiform Augmentation Material Straith Nasal Implant Odifile Nasal Implant Surgiform Nasal Implant ScarX Surgiform Chin Implant Straight Chin Surgiform Malar Implant

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EPP	Splint, Nasal	Ear, Nose, Throat	Class 1	874.5800	1979-05-22
FWP	Prosthesis, Chin, Internal	General, Plastic Surgery	Class 2	878.3550	2010-01-12
LZK	Implant, Malar	General, Plastic Surgery	Class 2	878.3550	2010-01-12
KKY	Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction	General, Plastic Surgery	Class 2	878.3500	2007-12-11
FZE	Prosthesis, Nose, Internal	General, Plastic Surgery	Class 2	878.3680	2007-12-11
PFP	Silicone Hydrogel For Scar Management	General, Plastic Surgery	Class 1	878.4025	2023-06-23
FWP	Prosthesis, Chin, Internal	General, Plastic Surgery	Class 2	878.3550	2007-12-11
LZK	Implant, Malar	General, Plastic Surgery	Class 2	878.3550	2007-12-11

Official Correspondent

MATHEW FAIRFAX

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SURGICAL TECHNOLOGY LABORATORIES 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
K080507	Ceremed , Inc.	AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT	2008-04-21

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1825527. Last updated year: 2026. Please use registration number 1825527 when referencing this establishment in official correspondence.