FDA.report

Endoskeletal Components

Primary DI
00195411269167
Brand
Endoskeletal Components
Company
COLLEGE PARK INDUSTRIES, INC.
Model
4HPA TP
Device description
4-Hole Pyramid Adapter, Standard, Ti, Pediatric
Published
2023-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
IQODevice, Prosthesis Alignment

Product Code Classifications

CodeDeviceSpecialtyClass
IQODevice, Prosthesis AlignmentPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00195411269167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00195411269167001954112691671954112691670195411269167

GMDN Terms

TermDefinition
External lower-limb prosthesis structural/alignment componentA component of an external lower limb prosthesis [hip, knee, or ankle-foot prosthesis] designed as: 1) a structural element to connect and maintain the structural integrity between the components of the prosthesis [e.g., between a socket and a knee joint prosthesis]; and/or 2) an alignment element to enable adjustment of the orientation of the prosthesis components relative to each other and to the patient (e.g., mediolateral shift, anteroposterior tilt). It may be in the form of a tube, pylon, adaptor, attachment block, clamp, pyramid, socket anchor, plate, or other design, and is intended to remain an integral part of the fitted prosthesis.

Sterilization Methods

Method

Contacts

PhoneEmail
1-800-728-7950orders@college-park.com

Regulatory Flags

DUNS number
623191137
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00841747186936Aura PlusAHKA 5002026-01-29
00841747186943Aura PlusAHKA 5502026-01-29
00195411458905IconIC CB G2025-05-28
00841747186912Endoskeletal ComponentsTA WT250 302025-05-28
00841747186929Endoskeletal ComponentsTA WT430 302025-05-28
00841747183973SterlingSLK G3L US12024-11-01
00841747183997SterlingSLK G3C UL22024-11-01
00841747184000SterlingSLK G3C UM+22024-11-01
00841747184017SterlingSLK G3C UM22024-11-01
00841747184024SterlingSLK G3C US22024-11-01
00841747184031SterlingSLK G9L UXL22024-11-01
00841747184048SterlingSLK G9L UL+22024-11-01
00841747184055SterlingSLK G9L UL22024-11-01
00841747184062SterlingSLK G9L UM+22024-11-01
00841747184079SterlingSLK G9L UM22024-11-01
00841747184086SterlingSLK G9L US22024-11-01
00841747184093SterlingSLK G6L UXL22024-11-01
00841747184109SterlingSLK G6L UL+22024-11-01
00841747184116SterlingSLK G6L UL22024-11-01
00841747184123SterlingSLK G6L UM+22024-11-01

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00841747186912Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2025-05-28
00841747186929Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2025-05-28
00195411036455Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411036622Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411036790Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411036813Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411108602Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192298Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192304Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192311Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192328Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192342Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192359Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192366Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192373Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192380Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192397Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192403Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192410Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192427Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411192434Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411214440Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411214457Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269150Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269174Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269181Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269198Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269204Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269211Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26
00195411269228Endoskeletal ComponentsCOLLEGE PARK INDUSTRIES, INC.IQO2023-10-26