FDA.reportPublic FDA data

NA

Primary DI
04042409068645
Brand
NA
Company
aap Implantate AG
Model
PR 3530-09
Catalog number
PR 3530-09
Device description
Straight Recon. Plate 3.5, 9 ACP holes, L 106
Published
2016-08-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072411000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072411000AAP BONE PLATES AND SCREW IMPLANTSAap Implantate AG2008-03-20HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04042409068645PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04042409068645040424090686454042409068645

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; it does not incorporate a sleeve or blade. Instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be included with the plate.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
328420633
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04042409200021NASC 4030-46-2SC 4030-46-22016-08-18
04042409200038NASC 4030-48-2SC 4030-48-22016-08-18
04042409200045NASC 4030-50-2SC 4030-50-22016-08-18
04042409200076NASC 4050-10-2SC 4050-10-22016-08-18
04042409200083NASC 4050-12-2SC 4050-12-22016-08-18
04042409200090NASC 4050-14-2SC 4050-14-22016-08-18
04042409200106NASC 4050-16-2SC 4050-16-22016-08-18
04042409200120NASC 4050-18-2SC 4050-18-22016-08-18
04042409200151NASC 4050-20-2SC 4050-20-22016-08-18
04042409200168NASC 4050-22-2SC 4050-22-22016-08-18
04042409236990NASC 4030-46SC 4030-462016-08-18
04042409237003NASC 4030-48SC 4030-482016-08-18
04042409237010NASC 4030-50SC 4030-502016-08-18
04042409237027NASC 4030-55SC 4030-552016-08-18
04042409035807NAIP 0104-002018-02-28
04042409035845NAIP 0104-012018-02-28
04042409002939NAIP 8403-002018-02-28
04042409036170NAIP 2505-002018-02-28
04042409207273NAIP 8405-002018-02-28
04042409228995NAIP 8405-502018-02-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888233028875Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233028882Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233028899Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086110Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086127Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086134Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086141Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086158Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086165Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086172Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086189Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086196Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086202Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086219Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
07613327649109T2, PANGEAStryker GmbHHRS2025-09-25
07613327649130T2, PANGEAStryker GmbHHRS2025-09-25
07613327649253T2, PANGEAStryker GmbHHRS2025-09-25
07613327649260T2, PANGEAStryker GmbHHRS2025-09-25
07613327649277T2, PANGEAStryker GmbHHRS2025-09-25
07613327649284T2, PANGEAStryker GmbHHRS2025-09-25
07613327649291T2, PANGEAStryker GmbHHRS2025-09-25
07613327649307T2, PANGEAStryker GmbHHRS2025-09-25
07613327649314T2, PANGEAStryker GmbHHRS2025-09-25
07613327649321T2, PANGEAStryker GmbHHRS2025-09-25
07613327649338T2, PANGEAStryker GmbHHRS2025-09-25
07613327649345T2, PANGEAStryker GmbHHRS2025-09-25
07613327649352T2, PANGEAStryker GmbHHRS2025-09-25
07613327649369T2, PANGEAStryker GmbHHRS2025-09-25
07613327649376T2, PANGEAStryker GmbHHRS2025-09-25
07613327649383T2, PANGEAStryker GmbHHRS2025-09-25