Composite Manufacturing, Inc.

FDA Device Registration & Listing · San Clemente, CA, US · Registration 2030380

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2030380
FEI Number
1000519805
Entity Name
Composite Manufacturing, Inc.
City/State/Country
San Clemente, CA, US
Establishment Address
970 B Calle Amanecer, San Clemente, CA 92673, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
COMPOSITE MFG., INC. (Owner Number: 9019788)
Owner / Operator Contact Address
970-B CALLE AMANECER, --, San Clemente, CA 92673, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FWZ Operating Room Accessories Table Tray General, Plastic Surgery Class 1 878.4950 2014-12-09
BWN Table And Attachments, Operating-Room General, Plastic Surgery Class 1 878.4950 2016-10-19
FQO Table, Operating-Room, Ac-Powered General, Plastic Surgery Class 1 878.4960 2023-07-14
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2023-08-08
HST Apparatus, Traction, Non-Powered Orthopedic Class 1 888.5850 2023-08-08
IPT Orthosis, Thoracic Physical Medicine Class 1 890.3490 2023-02-08

Official Correspondent

ROGER MALCOLM

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

COMPOSITE MFG., 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
K812396 Northwest Surgical Concepts, Inc. ARTHRO-PREP REST 1981-11-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2024 Getinge Usa Sales Inc 1
Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2
Z-0009-2007 Smith & Nephew Inc 1
Journey Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 74018811, 74018813, 74018815, 74018817.
Z-0010-2007 Smith & Nephew Inc 1
Genesis II Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71440480, 71440482, 71440484, 71440486
Z-0011-06 Stryker Howmedica Osteonics Corp. 1
Allocraft TLIF Bone Inserter.
Z-0011-2007 Smith & Nephew Inc 1
Genesis II Oversized Nonporous Fin-Stem Tibial Punch, Catalog Numbers: 71927102, 71927103, 71927104, 71927105

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2030380. Last updated year: 2026. Please use registration number 2030380 when referencing this establishment in official correspondence.
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