FDA.reportPublic FDA data

PC Fix Thoracic Plate 95mm PEEK

Primary DI
00850080543085
Brand
PC Fix Thoracic Plate 95mm PEEK
Company
Chest Wall Innovations, Inc.
Model
650.01.3009
Device description
PEEK rib fixation plate, 95 mm length, designed for thoracic placement with compatible locking posts and caps.
Published
2026-06-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, Fixation, Bone
HTNWasher, Bolt Nut

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HTNWasher, Bolt NutOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K260411000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K260411000PC Fix SystemChest Wall Innovations, Inc.2026-04-24HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850080543085PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850080543085008500805430858500805430850850080543085

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate, non-bioabsorbableA non-bioabsorbable, non-customized, firm, implantable sheet intended to stabilize a fractured orthopaedic bone (excluding craniofacial and spinal) to treat a traumatic/pathological fracture, to fuse a joint (arthrodesis) and/or as part of an osteotomy. Typically attached to a bone of a limb, rib, sternum, or pelvis, it is designed to be fixed in place with screws, and may be used in connection with another fixation plate; it does not incorporate a sleeve or blade. Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
717-553-0824support@chestwallinnovations.com

Regulatory Flags#

DUNS number
133806630
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850080543009PC Fix Locking Post Ti650.01.30012026-06-01
00850080543016PC Fix Locking Cap Ti650.01.30022026-06-01
00850080543023PC Fix Washer Ti650.01.30032026-06-01
00850080543030PC Fix Extrathoracic Plate 70mm Ti650.01.30042026-06-01
00850080543047PC Fix Extrathoracic Plate 95mm Ti650.01.30052026-06-01
00850080543054PC Fix Intrathoracic Plate 70mm Ti650.01.30062026-06-01
00850080543061PC Fix Intrathoracic Plate 95mm Ti650.01.30072026-06-01
00850080543078PC Fix Thoracic Plate 70mm PEEK650.01.30082026-06-01
00850080543092PC Fix 3.2mm Drill Brad Point QC650.02.00012026-06-01
00850080543108PC Fix Graphic Case650.03.20012026-06-01
00850080543115PC Fix Clamp/Drill Guide Top650.02.10012026-06-01
00850080543122PC Fix Clamp/Drill Guide Bottom650.02.10022026-06-01
00850080543139PC Fix Compression Clamp650.02.10032026-06-01
00850080543146PC Fix 3.2mm Drill Dental Latch650.02.00022026-06-01
00850080543184PC Fix Implant Caddy650.03.20022026-06-01

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