FDA.reportPublic FDA data

PC Fix Compression Clamp

Primary DI
00850080543139
Brand
PC Fix Compression Clamp
Company
Chest Wall Innovations, Inc.
Model
650.02.1003
Device description
Instrument used to approximate rib segments and maintain alignment during plate placement.
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
false

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
00850080543139PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850080543139008500805431398500805431390850080543139

GMDN Terms#

Term, Definition table
TermDefinition
Bone approximation clampA hand-held manual surgical instrument designed to grip and hold a bone or, being used in pairs one on either side of the fracture, to approximate the proximal and distal segment of a fractured bone during orthopaedic surgery. It is typically made of high-grade stainless steel and is designed with a double hooked, blade-like jaw at the distal end (this hooks over the upper edge of the bone) whilst an adjustable single hook is tightened against the lower edge of the bone through a screw mechanism. A traction bar may be employed to bridge the two bone clamps and using its screw mechanism, the fracture is drawn together. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
00850080543085PC Fix Thoracic Plate 95mm PEEK650.01.30092026-06-01
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
00850080543146PC Fix 3.2mm Drill Dental Latch650.02.00022026-06-01
00850080543184PC Fix Implant Caddy650.03.20022026-06-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00370056966385Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658151Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658175Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569658199Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569662202Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663247Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663841Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663865Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663872Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663889Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663896Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663902Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663919Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663926Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663933Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663940Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569663964Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569671327Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676438Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676445Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676452Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
03700569676469Xpert PFPNEWCLIP TECHNICSHRS2026-06-02
00850080543009PC Fix Locking Post TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543009PC Fix Locking Post TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543016PC Fix Locking Cap TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543016PC Fix Locking Cap TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543023PC Fix Washer TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543023PC Fix Washer TiChest Wall Innovations, Inc.HRS2026-06-01
00850080543030PC Fix Extrathoracic Plate 70mm TiChest Wall Innovations, Inc.HTN2026-06-01
00850080543030PC Fix Extrathoracic Plate 70mm TiChest Wall Innovations, Inc.HRS2026-06-01