Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2031913

FEI Number

3002926780

Entity Name

SPEC Engineering Co.

City/State/Country

Hawthorne, CA, US

Establishment Address

3210 W El Segundo Blvd., Hawthorne, CA 90250, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

SPEC Engineering Co. (Owner Number: 10042555)

Owner / Operator Contact Address

3210 W El Segundo Blvd., Hawthorne, CA 90250, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Screwdriver Gage, Depth Guide, Surgical Instrument ALPS SPEC

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HXX	Screwdriver	Orthopedic	Class 1	888.4540	2021-11-29
HTJ	Gauge, Depth	Orthopedic	Class 1	888.4300	2021-11-29
FZX	Guide, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2021-11-29
LXH	Orthopedic Manual Surgical Instrument	Orthopedic	Class 1	888.4540	2012-12-07

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

SPEC Engineering Co.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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
Z-0013-2011	Depuy Orthopaedics, Inc.	1	Summit Broach Handle, NON-STERILE, MFG: DEPUY ORTHOPAEDICS, INC., PO BOX 988 WARSAW, IN 46581, 1 800 366 8143 Catalog Number: 2570-00-000 The Summit Broach Handle (instrumentation) is used with the DePuy Summit Tapered Hip System. The Broach Handle is used to prepare the femur for hip system implantation. The broach handle is an impaction/extraction device that holds broaches for creating the cavity in the femur during hip arthroplasty.

Similar Registrations

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3009959868	Ferry Machine Corporation	Little Ferry, NJ, US
8010916	Kammerer Medical Systems GmbH & Co. KG	Stockach Baden-Wurttemberg, DE
3007689689	ELOS MEDTECH PINOL A/S	Goerloese Hovedstaden, DK
1038671	EXACTECH, INC.	GAINESVILLE, FL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2031913. Last updated year: 2026. Please use registration number 2031913 when referencing this establishment in official correspondence.